Viewing Study NCT02759120

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Ignite Creation Date: 2025-12-25 @ 4:13 AM
Ignite Modification Date: 2026-01-24 @ 4:31 AM
Study NCT ID: NCT02759120
Status: TERMINATED
Last Update Posted: 2021-04-08
First Post: 2016-04-28
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: CleanUP IPF for the Pulmonary Trials Cooperative
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elp2018@med.cornell.edu', 'phone': '646-962-2742', 'title': 'Elizabeth Peters', 'organization': 'Weill Cornell Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Thirty-five months', 'eventGroups': [{'id': 'EG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months', 'otherNumAtRisk': 254, 'deathsNumAtRisk': 254, 'otherNumAffected': 62, 'seriousNumAtRisk': 254, 'deathsNumAffected': 37, 'seriousNumAffected': 71}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care', 'otherNumAtRisk': 259, 'deathsNumAtRisk': 259, 'otherNumAffected': 23, 'seriousNumAtRisk': 259, 'deathsNumAffected': 37, 'seriousNumAffected': 65}], 'otherEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Idiopathic pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embollism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous system disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 51, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 29, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General disorders and administrative site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal and connective tissue disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury, poisoning, and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatobiliary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasm benign, malignant, and unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Product issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.83', 'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.53', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to up to 35 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death From Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.78', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to up to 35 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Non-elective, Respiratory Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '0.82', 'ciUpperLimit': '2.17', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to up to 35 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Non-elective, All-cause Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '0.91', 'ciUpperLimit': '2.01', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to up to 35 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of Non-elective Respiratory Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.40', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.89', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to up to 35 months', 'unitOfMeasure': 'hospitalizations', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of Non-elective All-cause Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.83', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to up to 35 months', 'unitOfMeasure': 'hospitalizations', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change in Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.99', 'groupId': 'OG000', 'lowerLimit': '-4.23', 'upperLimit': '-1.75'}, {'value': '-4.13', 'groupId': 'OG001', 'lowerLimit': '-5.28', 'upperLimit': '-2.98'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '2.83', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Randomization to 12 months', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.72', 'groupId': 'OG000', 'lowerLimit': '-3.27', 'upperLimit': '-0.18'}, {'value': '-2.56', 'groupId': 'OG001', 'lowerLimit': '-4.54', 'upperLimit': '-0.59'}]}]}], 'analyses': [{'pValue': '0.51', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '-1.67', 'ciUpperLimit': '3.35', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Randomization to 12 months', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of Respiratory Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.46', 'ciUpperLimit': '1.11', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to up to 35 months', 'unitOfMeasure': 'respiratory infections', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in UCSD-Shortness of Breath Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '5.67', 'groupId': 'OG000', 'lowerLimit': '2.75', 'upperLimit': '8.59'}, {'value': '6.29', 'groupId': 'OG001', 'lowerLimit': '3.54', 'upperLimit': '9.04'}]}]}], 'analyses': [{'pValue': '0.76', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-4.64', 'ciUpperLimit': '3.39', 'statisticalMethod': 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A lower score indicates a better health score. The UCSD-Shortness of Breath Questionnaire assesses the severity of shortness of breath during specific activities of daily living.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fatigue Severity Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '0.24', 'groupId': 'OG000', 'lowerLimit': '-0.02', 'upperLimit': '0.49'}, {'value': '0.13', 'groupId': 'OG001', 'lowerLimit': '-0.12', 'upperLimit': '0.37'}]}]}], 'analyses': [{'pValue': '0.54', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.46', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Randomization to 12 months', 'description': "Fatigue Severity Scale score (1 - 7 range). A lower score indicates a better health score. The Fatigue Severity Scale measures the severity of fatigue and its effect on a person's activities and lifestyle.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Leicester Cough Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.58', 'groupId': 'OG000', 'lowerLimit': '-1.15', 'upperLimit': '0.00'}, {'value': '-0.58', 'groupId': 'OG001', 'lowerLimit': '-1.13', 'upperLimit': '-0.04'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '0.80', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Randomization to 12 months', 'description': 'Leicester Cough Questionnaire score (3 - 21 range). A higher score indicates a better health score. The Leicester Cough Questionnaire measures quality of life in people with a chronic cough.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in EuroQol Index (EQ-5D) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.040', 'groupId': 'OG000', 'lowerLimit': '-0.071', 'upperLimit': '-0.009'}, {'value': '-0.046', 'groupId': 'OG001', 'lowerLimit': '-0.075', 'upperLimit': '-0.016'}]}]}], 'analyses': [{'pValue': '0.76', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-4.64', 'ciUpperLimit': '3.39', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Randomization to 12 months', 'description': 'European Quality of Life-5 dimensions (EQ-5D) score (0 - 1 range). A higher score indicates a better health score. The EQ-5D measures quality of life across 5 dimensions (1. Mobility, 2. Self-care, 3. Usual activities, 4. Pain/discomfort, 5. Anxiety/depression.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in ICEpop CAPability Measure for Older People (ICECAP-O) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '0.027', 'groupId': 'OG000', 'lowerLimit': '-0.003', 'upperLimit': '0.057'}, {'value': '0.017', 'groupId': 'OG001', 'lowerLimit': '-0.011', 'upperLimit': '0.045'}]}]}], 'analyses': [{'pValue': '0.63', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.010', 'ciLowerLimit': '-0.031', 'ciUpperLimit': '0.051', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Randomization to 12 months', 'description': 'Change in ICEpop (Investigating Choice Experiments for the Preferences of Older People) CAPability measure for Older people (ICECAP-O) score (0 - 1 range). A lower score indicates a better health score. The ICEpop CAPability measure for Older people (ICECAP-O) is intended for use in economic evaluations of care services for older people.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Short Form-12 Health Survey (SF-12) 6D Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.013', 'groupId': 'OG000', 'lowerLimit': '-0.031', 'upperLimit': '0.005'}, {'value': '-0.031', 'groupId': 'OG001', 'lowerLimit': '-0.048', 'upperLimit': '-0.014'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.018', 'ciLowerLimit': '-0.007', 'ciUpperLimit': '0.043', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Randomization to 12 months', 'description': 'Change in Short Form-12 health survey (SF-12) 6D score (0.29 - 1.00 range). A higher indicates a better health score. The SF-12 6D score provides and economic evaluation.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Short Form-12 Health Survey (SF-12) Physical Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.36', 'groupId': 'OG000', 'lowerLimit': '-2.54', 'upperLimit': '-0.18'}, {'value': '-1.88', 'groupId': 'OG001', 'lowerLimit': '-3.00', 'upperLimit': '-0.75'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '-1.11', 'ciUpperLimit': '2.15', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Randomization to 12 months', 'description': 'Change in short form-12 health survey (SF-12) physical component summary (PSC) score (0 - 100 range). A higher score indicates a better health score.\n\nThe short form-12 health survey physical score assesses limitations in physical activities because of health problems.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in SF-12 Health Survey (SF-12) Mental Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.29', 'groupId': 'OG000', 'lowerLimit': '-2.67', 'upperLimit': '0.09'}, {'value': '-1.59', 'groupId': 'OG001', 'lowerLimit': '-2.91', 'upperLimit': '-0.27'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-1.61', 'ciUpperLimit': '2.20', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Randomization to 12 months', 'description': 'Change in short form-12 health survey (SF-12) mental component summary (MCS) score (0 - 100 range). A higher score indicates a better health score.\n\nThe short form-12 health survey (SF-12) mental component summary (MCS) assesses general mental health.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients with IPF for comparison\n\nNo Intervention: Standard of Care: Standard of care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '254'}, {'groupId': 'FG001', 'numSubjects': '259'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}, {'groupId': 'FG001', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '79'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Moved out of area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lung transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other reason not completed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'BG000'}, {'value': '259', 'groupId': 'BG001'}, {'value': '513', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Antimicrobial Therapy Plus Standard of Care', 'description': 'Co-trimoxazole OR doxycycline\n\nAntimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Standard of care for patients 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[{'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'BG000'}, {'value': '259', 'groupId': 'BG001'}, {'value': '513', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'BG000'}, {'value': '259', 'groupId': 'BG001'}, {'value': '513', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '490', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'BG000'}, {'value': '259', 'groupId': 'BG001'}, {'value': '513', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '231', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '475', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'BG000'}, {'value': '259', 'groupId': 'BG001'}, 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'40.10', 'spread': '14.487', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data could not be located.'}, {'title': 'Diffusing capacity of the lung for carbon monoxide (DLCO) percent predicted (best available)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '484', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.68', 'spread': '16.939', 'groupId': 'BG000'}, {'value': '40.11', 'spread': '13.814', 'groupId': 'BG001'}, {'value': '40.38', 'spread': '15.384', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data could not be located.'}, {'title': 'GAP stage', 'classes': [{'title': 'I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '484', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}, {'title': 'II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '484', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}]}, {'title': 'III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '484', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The GAP stage assessment system is a clinical prediction tool that estimates prognosis in patients with idiopathic pulmonary fibrosis. The GAP model includes four baseline variables that were found to be predictive of outcome, as identified by logistic regression. These factors are: gender (G), age (A) and two lung physiology variables (P) (forced vital capacity and diffusing capacity of the lung for carbon monoxide). A higher stage indicates a higher rate of mortality.\n\nOne year mortality rates by stage:\n\nStage I = 6% Stage II=16% Stage III = 39%', 'unitOfMeasure': 'participants', 'populationDescription': 'Data could not be located.'}, {'title': 'University of California San Diego (UCSD) shortness of breath questionnaire total score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '508', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32.62', 'spread': '24.246', 'groupId': 'BG000'}, {'value': '32.91', 'spread': '32.91', 'groupId': 'BG001'}, {'value': '32.77', 'spread': '32.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ) total score (0 - 120 range). A lower score indicates a better health score.\n\nThe UCSD SOBQ is a 24-item self-administered questionnaire that assesses dyspnea associated with activities of daily living.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data could not be located.'}, {'title': 'EuroQoL index score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '505', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.191', 'groupId': 'BG000'}, {'value': '0.80', 'spread': '0.173', 'groupId': 'BG001'}, {'value': '0.80', 'spread': '0.182', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'EuroQoL score (0 - 1 range). A higher score indicates a better health score.\n\nThis self-administered instrument includes five health state items (e.g. mobility, self-care).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data could not be located.'}, {'title': 'EuroQoL thermometer response', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '430', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68.90', 'spread': '22.286', 'groupId': 'BG000'}, {'value': '69.78', 'spread': '20.044', 'groupId': 'BG001'}, {'value': '69.33', 'spread': '21.190', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'EuroQoL visual analog scale (0 - 100 range). A higher score indicates a better health score.\n\nIncludes a 0-100 "thermometer" rating of current state of health from 0 as worst imaginable to 100 as best.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data could not be located.'}, {'title': 'ICEpop CAPability Measure for Older People (ICECAP-O) Score summary score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '511', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.217', 'groupId': 'BG000'}, {'value': '0.36', 'spread': '0.209', 'groupId': 'BG001'}, {'value': '0.36', 'spread': '0.213', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'ICEpop CAPability Measure for Older People (ICECAP-O) Score (0 - 1 range). A lower score indicates a better health score. The ICECAP-O is a measure of capability in older people for use in economic evaluation.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data could not be located.'}, {'title': 'SF12 mental component summary (MCS) score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.217', 'groupId': 'BG000'}, {'value': '0.36', 'spread': '0.209', 'groupId': 'BG001'}, {'value': '0.36', 'spread': '0.213', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Short Form-12 mental component summary (MCS) score (0 - 100 range). A higher score indicates a better health score.\n\nThe Short Form 12 MSC score assess mental health and well-being.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data could not be located.'}, {'title': 'SF12 physical component summary (PCS) score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '509', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41.46', 'spread': '8.776', 'groupId': 'BG000'}, {'value': '40.23', 'spread': '9.171', 'groupId': 'BG001'}, {'value': '40.83', 'spread': '8.991', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Short form-12 physical components summary (PSC) score (0 - 100 range). A higher score indicates a better health score.\n\nThe Short form-12 PSC score assesses limitations in physical activity because of health problems.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data could not be located.'}, {'title': 'SF6D score (economic evaluation)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.72', 'spread': '0.115', 'groupId': 'BG000'}, {'value': '0.72', 'spread': '0.114', 'groupId': 'BG001'}, {'value': '0.72', 'spread': '0.115', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Short form-12 6D health survey score (0.29 - 1.00 range). A higher score indicates a better health score.\n\nThe Short form-12 6D health survey provides an economical evaluation.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data could not be located.'}, {'title': 'Fatigue Severity Scale score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'BG000'}, {'value': '253', 'groupId': 'BG001'}, {'value': '505', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.81', 'spread': '1.554', 'groupId': 'BG000'}, {'value': '3.98', 'spread': '1.708', 'groupId': 'BG001'}, {'value': '3.90', 'spread': '1.633', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Fatigue Severity Score (1 - 7 range). A lower score indicates a better health score. The fatigue severity questionnaire measures how fatigue impacts one's ability to function in the last week.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data could not be located.'}, {'title': 'Leicester cough questionnaire total score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '506', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16.71', 'spread': '3.681', 'groupId': 'BG000'}, {'value': '17.19', 'spread': '3.589', 'groupId': 'BG001'}, {'value': '16.95', 'spread': '3.638', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Leicester cough questionnaire total score (3 - 21 range). A higher score indicates a better health score.\n\nThe Leicester cough questionnaire assesses symptoms of cough frequency and severity.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data could not be located.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-28', 'size': 1590741, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-12-14T19:18', 'hasProtocol': False}, {'date': '2018-03-02', 'size': 2154223, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-17T17:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 513}}, 'statusModule': {'whyStopped': 'Terminated for futility after review of first planned interim analysis.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-11', 'studyFirstSubmitDate': '2016-04-28', 'resultsFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2016-04-28', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-09', 'studyFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality', 'timeFrame': 'Randomization to up to 35 months'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Death From Any Cause', 'timeFrame': 'Randomization to up to 35 months'}, {'measure': 'Number of Participants With First Non-elective, Respiratory Hospitalization', 'timeFrame': 'Randomization to up to 35 months'}, {'measure': 'Number of Participants With First Non-elective, All-cause Hospitalization', 'timeFrame': 'Randomization to up to 35 months'}, {'measure': 'Total Number of Non-elective Respiratory Hospitalizations', 'timeFrame': 'Randomization to up to 35 months'}, {'measure': 'Total Number of Non-elective All-cause Hospitalizations', 'timeFrame': 'Randomization to up to 35 months'}, {'measure': 'Percent Change in Forced Vital Capacity (FVC)', 'timeFrame': 'Randomization to 12 months'}, {'measure': 'Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)', 'timeFrame': 'Randomization to 12 months'}, {'measure': 'Total Number of Respiratory Infections', 'timeFrame': 'Randomization to up to 35 months'}, {'measure': 'Change in UCSD-Shortness of Breath Questionnaire', 'timeFrame': 'Randomization to 12 months', 'description': 'Change in University of California San Diego (UCSD) Shortness of Breath Questionnaire (0 - 120 range). A lower score indicates a better health score. The UCSD-Shortness of Breath Questionnaire assesses the severity of shortness of breath during specific activities of daily living.'}, {'measure': 'Change in Fatigue Severity Scale Score', 'timeFrame': 'Randomization to 12 months', 'description': "Fatigue Severity Scale score (1 - 7 range). A lower score indicates a better health score. The Fatigue Severity Scale measures the severity of fatigue and its effect on a person's activities and lifestyle."}, {'measure': 'Change in Leicester Cough Questionnaire Score', 'timeFrame': 'Randomization to 12 months', 'description': 'Leicester Cough Questionnaire score (3 - 21 range). A higher score indicates a better health score. The Leicester Cough Questionnaire measures quality of life in people with a chronic cough.'}, {'measure': 'Change in EuroQol Index (EQ-5D) Score', 'timeFrame': 'Randomization to 12 months', 'description': 'European Quality of Life-5 dimensions (EQ-5D) score (0 - 1 range). A higher score indicates a better health score. The EQ-5D measures quality of life across 5 dimensions (1. Mobility, 2. Self-care, 3. Usual activities, 4. Pain/discomfort, 5. Anxiety/depression.'}, {'measure': 'Change in ICEpop CAPability Measure for Older People (ICECAP-O) Score', 'timeFrame': 'Randomization to 12 months', 'description': 'Change in ICEpop (Investigating Choice Experiments for the Preferences of Older People) CAPability measure for Older people (ICECAP-O) score (0 - 1 range). A lower score indicates a better health score. The ICEpop CAPability measure for Older people (ICECAP-O) is intended for use in economic evaluations of care services for older people.'}, {'measure': 'Change in Short Form-12 Health Survey (SF-12) 6D Score', 'timeFrame': 'Randomization to 12 months', 'description': 'Change in Short Form-12 health survey (SF-12) 6D score (0.29 - 1.00 range). A higher indicates a better health score. The SF-12 6D score provides and economic evaluation.'}, {'measure': 'Change in Short Form-12 Health Survey (SF-12) Physical Score', 'timeFrame': 'Randomization to 12 months', 'description': 'Change in short form-12 health survey (SF-12) physical component summary (PSC) score (0 - 100 range). A higher score indicates a better health score.\n\nThe short form-12 health survey physical score assesses limitations in physical activities because of health problems.'}, {'measure': 'Change in SF-12 Health Survey (SF-12) Mental Score', 'timeFrame': 'Randomization to 12 months', 'description': 'Change in short form-12 health survey (SF-12) mental component summary (MCS) score (0 - 100 range). A higher score indicates a better health score.\n\nThe short form-12 health survey (SF-12) mental component summary (MCS) assesses general mental health.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Idiopathic Pulmonary Fibrosis', 'IPF', 'pulmonary fibrosis', 'antimicrobial therapy', 'doxycycline', 'co-trimoxazole'], 'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'referencesModule': {'references': [{'pmid': '38030064', 'type': 'DERIVED', 'citation': 'Kim JS, Murray S, Yow E, Anstrom KJ, Kim HJ, Flaherty KR, Martinez FJ, Noth I. Comparison of Pirfenidone and Nintedanib: Post Hoc Analysis of the CleanUP-IPF Study. Chest. 2024 May;165(5):1163-1173. doi: 10.1016/j.chest.2023.11.035. Epub 2023 Nov 27.'}, {'pmid': '33974018', 'type': 'DERIVED', 'citation': 'Martinez FJ, Yow E, Flaherty KR, Snyder LD, Durheim MT, Wisniewski SR, Sciurba FC, Raghu G, Brooks MM, Kim DY, Dilling DF, Criner GJ, Kim H, Belloli EA, Nambiar AM, Scholand MB, Anstrom KJ, Noth I; CleanUP-IPF Investigators of the Pulmonary Trials Cooperative. Effect of Antimicrobial Therapy on Respiratory Hospitalization or Death in Adults With Idiopathic Pulmonary Fibrosis: The CleanUP-IPF Randomized Clinical Trial. JAMA. 2021 May 11;325(18):1841-1851. doi: 10.1001/jama.2021.4956.'}, {'pmid': '32164673', 'type': 'DERIVED', 'citation': 'Anstrom KJ, Noth I, Flaherty KR, Edwards RH, Albright J, Baucom A, Brooks M, Clark AB, Clausen ES, Durheim MT, Kim DY, Kirchner J, Oldham JM, Snyder LD, Wilson AM, Wisniewski SR, Yow E, Martinez FJ; CleanUP-IPF Study Team. Design and rationale of a multi-center, pragmatic, open-label randomized trial of antimicrobial therapy - the study of clinical efficacy of antimicrobial therapy strategy using pragmatic design in Idiopathic Pulmonary Fibrosis (CleanUP-IPF) clinical trial. Respir Res. 2020 Mar 12;21(1):68. doi: 10.1186/s12931-020-1326-1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effect of standard care, versus standard of care plus antimicrobial therapy (co-trimoxazole or doxycycline), on clinical outcomes in patients diagnosed with idiopathic pulmonary fibrosis (IPF).', 'detailedDescription': 'This is a randomized, un-blinded, phase III, multi-center clinical trial of an antimicrobial therapy strategy in idiopathic pulmonary fibrosis patients. Our overall hypothesis is that reducing harmful microbial impact with antimicrobial therapy will reduce the risk of non-elective, respiratory hospitalization or death in patients with Idiopathic Pulmonary Fibrosis (IPF).\n\nSubjects will be randomized 1:1 to either receive a prescription drug voucher for oral antimicrobial therapy in the form of one double strength 160 milligrams (mg) trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms (kg) or 100mg twice daily if weight \\> 50 kg. Patients randomized to receive antimicrobial therapy will be given co-trimoxazole unless they have an allergy, contraindication to co-trimoxazole, renal insufficiency (glomerular filtration rate (GFR) \\< 30 milliliters (ml)), are hyperkalemic (potassium \\> 5 milliequivalents(mEq)/liter(L)), or are concomitantly taking an angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), or potassium sparing diuretic in which case they will receive doxycycline.\n\nParticipation in this study will be between 12 months and 36 months depending on time of enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 40 years of age\n2. Diagnosed with idiopathic pulmonary fibrosis (IPF) by enrolling investigator\n3. Signed informed consent\n\nExclusion Criteria:\n\n1. Received antimicrobial therapy in the past 30 days\n2. Contraindicated for antibiotic therapy, including but not exclusive to:\n\n 1. Allergy or intolerance to both tetracyclines AND trimethoprim, sulfonamides or their combination\n 2. Allergy or intolerance to tetracyclines AND known potassium level \\> 5 mEq/L in the past 90 days.\n\n * If the enrolling physician feels the potassium level has normalized, documentation to that effect must be provided.\n 3. Allergy or intolerance to tetracyclines AND concomitant use of angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), potassium sparing diuretic, dofetilide, methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide\n 4. Allergy or intolerance to tetracyclines AND known glucose-6-phosphate dehydrogenase deficiency\n 5. Allergy or intolerance to tetracyclines AND untreated folate or B12 deficiency\n 6. Allergy or intolerance to tetracyclines AND known renal insufficiency (defined as a glomerular filtration rate (GFR) \\< 30 ml within the previous 90 days)\n\n * If the enrolling physician feels the renal dysfunction has resolved, documentation to that effect must be provided.\n3. Pregnant or anticipate becoming pregnant\n4. Use of an investigational study agent for IPF therapy within the past 30 days, or an IV infusion with a half-life of four (4) weeks.\n5. Concomitant immunosuppression with azathioprine, mycophenolate, cyclophosphamide, or cyclosporine.'}, 'identificationModule': {'nctId': 'NCT02759120', 'acronym': 'CleanUp-IPF', 'briefTitle': 'CleanUP IPF for the Pulmonary Trials Cooperative', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Study of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': '1504016087'}, 'secondaryIdInfos': [{'id': 'U01HL128954', 'link': 'https://reporter.nih.gov/quickSearch/U01HL128954', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antimicrobial therapy', 'description': 'Co-trimoxazole OR doxycycline', 'interventionNames': ['Drug: Antimicrobial therapy: Co-trimoxazole or Doxycycline']}, {'type': 'OTHER', 'label': 'Standard of care', 'description': 'Standard of care for patients with IPF for comparison', 'interventionNames': ['Other: No Intervention: Standard of Care']}], 'interventions': [{'name': 'Antimicrobial therapy: Co-trimoxazole or Doxycycline', 'type': 'DRUG', 'description': '160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \\< 50 kilograms or 100mg twice daily if weight \\> 50 kilograms for up to 36 months', 'armGroupLabels': ['Antimicrobial therapy']}, {'name': 'No Intervention: Standard of Care', 'type': 'OTHER', 'description': 'Standard of care', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': 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