Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-01-09 @ 3:03 AM
Study NCT ID:
NCT03867734
Status:
COMPLETED
Last Update Posted:
2022-01-18
First Post:
2019-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aztreonam for Pharyngeal Gonorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006069', 'term': 'Gonorrhea'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001398', 'term': 'Aztreonam'}], 'ancestors': [{'id': 'D008997', 'term': 'Monobactams'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lbarbee@uw.edu', 'phone': '206-744-2595', 'title': 'Lindley A. Barbee, MD, MPH', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Thirty minutes after injections and then over the following 4 - 6 days or until Test of Cure Visit.', 'description': 'We observed participants for 30 minutes following injection of aztreonam for Type 1 allergic reaction (i.e. IgE mediated-anaphylaxis reactions). A study clinician evaluated participants 4-7 days following aztreonam injection and asked about interim side effects. Aztreonam is usually a very well tolerated. Documented side effects (including, neutropenia, eosinophilia, thrombocytopenia, elevated liver function tests, skin rash, diarrhea, nausea, and vomiting) occur in \\<2% of cases.', 'eventGroups': [{'id': 'EG000', 'title': '2g Aztreonam', 'description': 'Subjects to receive 2g Aztreonam IM for the treatment of gonorrhea\n\nAztreonam: 2g IM Aztreonam', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 6, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Efficacy of Pharyngeal Gonorrhea as Defined as the Proportion of Study Participants With Positive Pharyngeal Gonorrhea Culture at of Enrollment Whose Test of Cure Pharyngeal Culture is Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharyngeal Gonorrhea -- Evaluable Population', 'description': 'Subjects who were Pharyngeal Gonorrhea Culture Positive at Enrollment and Received 2g Aztreonam intramuscularly (IM) and Returned for Test of Cure (TOC)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-7 days following treatment', 'description': 'Negative Test of Cure (i.e. Pharyngeal Gonorrhea Culture) after Treatment', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with pharyngeal culture positive for gonorrhea at enrollment'}, {'type': 'SECONDARY', 'title': 'Efficacy of 2 g Aztreonam for N. Gonorrhoeae at Anogenital Sites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efficacy of 2g Aztreonam for Urethral Gonorrhea', 'description': 'Subjects with culture-positive urethral gonorrhea who received 2g Aztreonam IM and returned for TOC\n\nAztreonam: 2g IM Aztreonam'}, {'id': 'OG001', 'title': 'Efficacy of 2g Aztreonam for Rectal Gonorrhea', 'description': 'Subjects with culture-positive gonorrhea of the rectum, treated with 2g Aztreonam and returned for TOC'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Test of Cure 4-7 days following treatment', 'description': 'Number of individuals with a negative N. gonorrhoeae culture at an anogenital site at test of cure among those who were N. gonorrhoeae culture positive at the respective anatomic site at the enrollment visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tolerability of 2g Aztreonam IM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '2g Aztreonam', 'description': 'All subjects who received 2g Aztreonam IM for the treatment of gonorrhea\n\nAztreonam: 2g IM Aztreonam'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately following injection', 'description': "Subjects' self-report of injection related pain on a scale from 0 - 10 where 0 is no pain and 10 is the worst pain ever.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Side Effects of 2g Aztreonam IM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '2g Aztreonam', 'description': 'Subjects to receive 2g Aztreonam IM for the treatment of gonorrhea\n\nAztreonam: 2g IM Aztreonam'}], 'classes': [{'title': 'reported having a HEADACHE', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'reported having NAUSEA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'assessed immediately following injection and 4-7 days after injection', 'description': "Subject's report of perceived side effects related to study drug based on responses to standard side effect questionnaire.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 30 participants who returned for Test of Cure Visit, 6 reported having a possible side effects between treatment and Test of Cure (4-7 days post injection)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2g Aztreonam', 'description': 'Subjects to receive 2g Aztreonam IM for the treatment of gonorrhea\n\nAztreonam: 2g IM Aztreonam'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '2g Aztreonam', 'description': 'Subjects to receive 2g Aztreonam IM for the treatment of gonorrhea\n\nAztreonam: 2g IM Aztreonam'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HIV co-infection', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex partner by gender', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Trans/nonbinary', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'partners'}, {'title': 'Number of oral sex partners in past 2 months (median range)', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'partners', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-26', 'size': 592032, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-05T14:33', 'hasProtocol': True}, {'date': '2019-04-18', 'size': 169610, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-11-10T16:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Demonstration Study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-06', 'studyFirstSubmitDate': '2019-03-04', 'resultsFirstSubmitDate': '2021-10-12', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-09', 'studyFirstPostDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Efficacy of Pharyngeal Gonorrhea as Defined as the Proportion of Study Participants With Positive Pharyngeal Gonorrhea Culture at of Enrollment Whose Test of Cure Pharyngeal Culture is Negative', 'timeFrame': '4-7 days following treatment', 'description': 'Negative Test of Cure (i.e. Pharyngeal Gonorrhea Culture) after Treatment'}], 'secondaryOutcomes': [{'measure': 'Efficacy of 2 g Aztreonam for N. Gonorrhoeae at Anogenital Sites', 'timeFrame': 'Test of Cure 4-7 days following treatment', 'description': 'Number of individuals with a negative N. gonorrhoeae culture at an anogenital site at test of cure among those who were N. gonorrhoeae culture positive at the respective anatomic site at the enrollment visit.'}, {'measure': 'Tolerability of 2g Aztreonam IM', 'timeFrame': 'Immediately following injection', 'description': "Subjects' self-report of injection related pain on a scale from 0 - 10 where 0 is no pain and 10 is the worst pain ever."}, {'measure': 'Side Effects of 2g Aztreonam IM', 'timeFrame': 'assessed immediately following injection and 4-7 days after injection', 'description': "Subject's report of perceived side effects related to study drug based on responses to standard side effect questionnaire."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aztreonam', 'treatment study'], 'conditions': ['Gonorrhea of Pharynx', 'Gonorrhea']}, 'referencesModule': {'references': [{'pmid': '33077658', 'type': 'DERIVED', 'citation': 'Barbee LA, Soge OO, Ocbamichael N, LeClair A, Golden MR. Single-Arm Open-Label Clinical Trial of Two Grams of Aztreonam for the Treatment of Neisseria gonorrhoeae. Antimicrob Agents Chemother. 2020 Dec 16;65(1):e01739-20. doi: 10.1128/AAC.01739-20. Print 2020 Dec 16.'}]}, 'descriptionModule': {'briefSummary': "The Centers for Disease Control and Prevention has identified antimicrobial-resistant (AMR) Neisseria gonorrhoeae (NG) as one of the nation's top three urgent AMR threats. Since the advent of antibiotics in the 1930s, NG has developed resistance to every first-line antibiotic. Parenteral third-generation cephalosporins are now the only class of drug with consistent efficacy against NG. New therapies are urgently needed. Although some novel antimicrobials are under development, reevaluating older drugs is another option for quickly identifying additional treatments for gonorrhea. We propose a demonstration study to test a single dose of aztreonam for the treatment of pharyngeal gonorrhea. We chose to focus on pharyngeal gonorrhea because these infections are common, play an important role in fostering gonococcal resistance, and are harder to eradicate than genital infections. Although aztreonam appears to be \\>98.6% efficacious for anogenital NG, its efficacy at the pharynx may be less. Only 8 cases of pharyngeal gonorrhea have been documented to be treated with aztreonam, but of those, only 5 (62.5%) were cured. The dose used in those studies was 1g of aztreonam. Most antibiotics have a lower efficacy at the pharynx than anogenital sites, which is likely due to drug pharmacokinetics, i.e. difficulty in penetrating pharyngeal tissue. Thus, in the proposed study, we plan to treat 50 subjects with untreated pharyngeal gonorrhea with 2g IM Aztreonam.\n\nObjectives:\n\nThe proposed study aims to evaluate the efficacy of a single 2g intramuscular (IM) dose of aztreonam in the treatment of pharyngeal gonorrhea. Secondary objectives include documenting the efficacy stratified by minimal inhibitory concentration (MIC) compared with the previously document area under the curve (AUC) in order to estimate a pharmacodynamic criterion. We will also attempt to determine whether aztreonam monotherapy induces antimicrobial resistance among treatment failures. Lastly, we will evaluate the tolerability of 2g of IM aztreonam. The specific aims are:\n\n1. Determine the proportion of persons whose pharyngeal gonococcal infections are cured with a single dose of 2g aztreonam intramuscularly.\n2. Determine the proportion of persons with urethral and/or rectal gonorrhea whose infections are cured with a single dose of 2g aztreonam IM.\n3. Evaluate the tolerability of 2g IM of aztreonam .\n4. Estimate the best pharmacodynamics criterion (i.e. AUC/MIC ratio) for pharyngeal gonorrhea treated with aztreonam using previously published AUC for 2g aztreonam and NG isolate MIC.\n5. Among treatment failures, conduct exploratory analyses comparing pre- and post-treatment MIC for evidence of induced resistance.\n\nStudy Design: Prospective cohort\n\nStudy Population \\& Inclusion Criteria:\n\nPersons diagnosed with pharyngeal gonorrhea or gonococcal urethritis who are undergoing pharyngeal gonorrhea testing, who are not yet treated.\n\nIntervention: 2g IM aztreonam x 1\n\nPrimary Outcome: Negative gonorrhea culture 4-7 days (+/- 1 day) after treatment\n\nSample Size: 50 persons"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Persons diagnosed with pharyngeal gonorrhea or gonococcal urethritis who are undergoing pharyngeal gonorrhea testing, who are not yet treated.\n\nExclusion Criteria:\n\n* Age less than 16 years\n* Receipt of antibiotics in ≤30 days\n* Known allergy to aztreonam\n* History of renal disease (including diagnosis of solitary kidney, chronic renal insufficiency, renal cell carcinoma etc.)\n* Concurrent infection with syphilis or chlamydia\n* Pregnancy and/or nursing\n* Unable to return for a follow-up visit 4-7 days (+/- 1 day).\n* Study team's discretion"}, 'identificationModule': {'nctId': 'NCT03867734', 'briefTitle': 'Aztreonam for Pharyngeal Gonorrhea', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Aztreonam for Pharyngeal Gonorrhea: A Demonstration Study', 'orgStudyIdInfo': {'id': 'STUDY00003878-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2g Aztreonam', 'description': 'Subjects to receive 2g Aztreonam IM for the treatment of gonorrhea', 'interventionNames': ['Drug: Aztreonam']}], 'interventions': [{'name': 'Aztreonam', 'type': 'DRUG', 'description': '2g IM Aztreonam', 'armGroupLabels': ['2g Aztreonam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Public Health -- Seattle & King County STD Clinic', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Lindley Barbee, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Lindley Barbee', 'investigatorAffiliation': 'University of Washington'}}}}