Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2026-01-18 @ 2:39 PM
Study NCT ID:
NCT01789203
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2013-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ciprofloxacin for Prevention of BK Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'spatel2@houstonmethodist.org', 'phone': '267-808-0577', 'title': 'Samir Patel', 'organization': 'Methodist Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant\n\nCiprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.', 'otherNumAtRisk': 133, 'deathsNumAtRisk': 133, 'otherNumAffected': 108, 'seriousNumAtRisk': 133, 'deathsNumAffected': 1, 'seriousNumAffected': 35}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant\n\nplacebo', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 55, 'seriousNumAtRisk': 67, 'deathsNumAffected': 1, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteopenia/osteoperosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clostridium difficile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cytomegalovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GI bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nonfunctinal nephrostomy tube', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Radial nerve palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound infection/complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Developing BK Infection at 6 Months Post-transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant\n\nCiprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant\n\nplacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number of patients (followed by proportion) developing BK infection at 6 months post-transplant. BK infection is defined as the presence of a detectable BK viral load in plasma by polymerase chain reaction (PCR), or the presence of BK viral inclusions on kidney biopsy specimens.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Gram Negative Urinary Tract Infections at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant\n\nCiprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant\n\nplacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number of patients with gram negative urinary tract infections as defined by a midstream urine sample containing 10\\^4 or more colony-forming units per mL', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Bacteremia at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant\n\nCiprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant\n\nplacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number of patients with bacteremic infection at 6 months. Bacteremia defined by a single positive blood culture that was not thought to be contaminated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Quinolone-resistant Infection at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant\n\nCiprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant\n\nplacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number of patients with quinolone-resistant gram negative bacterial infections, among those with a gram-negative infection', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clostridium Difficile at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant\n\nCiprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant\n\nplacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Clostridium difficile infection at 6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant\n\nCiprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant\n\nplacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months', 'description': 'Serious adverse events collected for up to 4 months (3 months on study drug plus 1 additional month)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to BK Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant\n\nCiprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant\n\nplacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '160'}, {'value': '76.5', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '295'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'Median time to initial BK viremia episode, days', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Included 31 ciprofloxacin and 8 placebo patients who became BK viremic during the first 12 months'}, {'type': 'SECONDARY', 'title': 'BK Viremia at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant\n\nCiprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant\n\nplacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Proportion of patients developing BK viremia at 1 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'First Plasma Viral Loads', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant\n\nCiprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant\n\nplacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2514', 'groupId': 'OG000', 'lowerLimit': '796', 'upperLimit': '8754'}, {'value': '1423', 'groupId': 'OG001', 'lowerLimit': '724', 'upperLimit': '19619'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'First BK plasma viral loads', 'unitOfMeasure': 'copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'included 31 ciprofloxacin and 8 placebo patients who became BK viremic during the first year'}, {'type': 'SECONDARY', 'title': 'Acute Rejection at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant\n\nCiprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant\n\nplacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Number of patients with biopsy-proven acute rejection of the allograft at 1 year, based on Banff classification', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Graft Loss at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant\n\nCiprofloxacin: Patients will be randomized 2:1 active comparator, Cipro, to placebo comparator.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant\n\nplacebo: Patients will be randomized 2:1 placebo comparator to active comparator, Cipro.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'kidney failure within first 1 year of transplant', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Death at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant\n\nCiprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant\n\nplacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Patient death at 1 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant\n\nCiprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant\n\nplacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'patient non-adherent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant\n\nCiprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant\n\nplacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '58'}, {'value': '44', 'groupId': 'BG001', 'lowerLimit': '37', 'upperLimit': '57'}, {'value': '48', 'groupId': 'BG002', 'lowerLimit': '39', 'upperLimit': '58'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}, {'title': 'Other or Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Repeat Transplant', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis performed on IIT patients (all randomized patients)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-30', 'size': 379414, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-09T10:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-25', 'studyFirstSubmitDate': '2013-02-07', 'resultsFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2013-02-11', 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-25', 'studyFirstPostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Graft Loss at 1 Year', 'timeFrame': '12 months', 'description': 'kidney failure within first 1 year of transplant'}, {'measure': 'Death at 1 Year', 'timeFrame': '12 months', 'description': 'Patient death at 1 year'}], 'primaryOutcomes': [{'measure': 'Number of Patients Developing BK Infection at 6 Months Post-transplant', 'timeFrame': '6 months', 'description': 'Number of patients (followed by proportion) developing BK infection at 6 months post-transplant. BK infection is defined as the presence of a detectable BK viral load in plasma by polymerase chain reaction (PCR), or the presence of BK viral inclusions on kidney biopsy specimens.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Gram Negative Urinary Tract Infections at 6 Months', 'timeFrame': '6 months', 'description': 'Number of patients with gram negative urinary tract infections as defined by a midstream urine sample containing 10\\^4 or more colony-forming units per mL'}, {'measure': 'Number of Patients With Bacteremia at 6 Months', 'timeFrame': '6 months', 'description': 'Number of patients with bacteremic infection at 6 months. Bacteremia defined by a single positive blood culture that was not thought to be contaminated.'}, {'measure': 'Number of Patients With Quinolone-resistant Infection at 6 Months', 'timeFrame': '6 months', 'description': 'Number of patients with quinolone-resistant gram negative bacterial infections, among those with a gram-negative infection'}, {'measure': 'Clostridium Difficile at 6 Months', 'timeFrame': '6 months', 'description': 'Clostridium difficile infection at 6 months'}, {'measure': 'Serious Adverse Events', 'timeFrame': '4 months', 'description': 'Serious adverse events collected for up to 4 months (3 months on study drug plus 1 additional month)'}, {'measure': 'Time to BK Infection', 'timeFrame': '12 months', 'description': 'Median time to initial BK viremia episode, days'}, {'measure': 'BK Viremia at 1 Year', 'timeFrame': '12 months', 'description': 'Proportion of patients developing BK viremia at 1 year'}, {'measure': 'First Plasma Viral Loads', 'timeFrame': '12 months', 'description': 'First BK plasma viral loads'}, {'measure': 'Acute Rejection at 1 Year', 'timeFrame': '12 months', 'description': 'Number of patients with biopsy-proven acute rejection of the allograft at 1 year, based on Banff classification'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BK infection', 'BK viremia', 'BK nephropathy', 'polyomavirus', 'fluoroquinolone', 'ciprofloxacin'], 'conditions': ['BK Virus Infection']}, 'referencesModule': {'references': [{'pmid': '15707414', 'type': 'BACKGROUND', 'citation': 'Brennan DC, Agha I, Bohl DL, Schnitzler MA, Hardinger KL, Lockwood M, Torrence S, Schuessler R, Roby T, Gaudreault-Keener M, Storch GA. Incidence of BK with tacrolimus versus cyclosporine and impact of preemptive immunosuppression reduction. Am J Transplant. 2005 Mar;5(3):582-94. doi: 10.1111/j.1600-6143.2005.00742.x.'}, {'pmid': '17503741', 'type': 'BACKGROUND', 'citation': 'Ali SH, Chandraker A, DeCaprio JA. Inhibition of Simian virus 40 large T antigen helicase activity by fluoroquinolones. Antivir Ther. 2007;12(1):1-6.'}, {'pmid': '15712075', 'type': 'BACKGROUND', 'citation': 'Leung AY, Chan MT, Yuen KY, Cheng VC, Chan KH, Wong CL, Liang R, Lie AK, Kwong YL. Ciprofloxacin decreased polyoma BK virus load in patients who underwent allogeneic hematopoietic stem cell transplantation. Clin Infect Dis. 2005 Feb 15;40(4):528-37. doi: 10.1086/427291. Epub 2005 Jan 21.'}, {'pmid': '21185389', 'type': 'BACKGROUND', 'citation': 'Miller AN, Glode A, Hogan KR, Schaub C, Kramer C, Stuart RK, Costa LJ. Efficacy and safety of ciprofloxacin for prophylaxis of polyomavirus BK virus-associated hemorrhagic cystitis in allogeneic hematopoietic stem cell transplantation recipients. Biol Blood Marrow Transplant. 2011 Aug;17(8):1176-81. doi: 10.1016/j.bbmt.2010.12.700. Epub 2010 Dec 23.'}, {'pmid': '20507960', 'type': 'BACKGROUND', 'citation': 'Gabardi S, Waikar SS, Martin S, Roberts K, Chen J, Borgi L, Sheashaa H, Dyer C, Malek SK, Tullius SG, Vadivel N, Grafals M, Abdi R, Najafian N, Milford E, Chandraker A. Evaluation of fluoroquinolones for the prevention of BK viremia after renal transplantation. Clin J Am Soc Nephrol. 2010 Jul;5(7):1298-304. doi: 10.2215/CJN.08261109. Epub 2010 May 27.'}, {'pmid': '39382091', 'type': 'DERIVED', 'citation': 'Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.'}, {'pmid': '30811872', 'type': 'DERIVED', 'citation': 'Patel SJ, Knight RJ, Kuten SA, Graviss EA, Nguyen DT, Moore LW, Musick WL, Gaber AO. Ciprofloxacin for BK viremia prophylaxis in kidney transplant recipients: Results of a prospective, double-blind, randomized, placebo-controlled trial. Am J Transplant. 2019 Jun;19(6):1831-1837. doi: 10.1111/ajt.15328. Epub 2019 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'BK infection is an important cause of graft dysfunction and graft loss after renal transplantation. It has been widely accepted that emergence of BK virus correlates with the more potent immunosuppressive agents used to lower acute rejection rates. In contrast to other opportunistic infections after transplantation, for which routine prophylactic agents are administered, there is no effective agent for the prevention of BK infection. Some data, however, suggests that quinolone antibiotics such as ciprofloxacin may have activity against BK virus. This has led us to investigate whether routine, short-term ciprofloxacin administration post-transplant can lower the incidence of BK infection.', 'detailedDescription': 'BK virus is a member of the virus family polyomaviridae ("polyoma"). The virus, which can manifest as a viral nephritis, was first described in a renal transplant recipient in 1971, however it was not until the past decade that infection with BK virus became known as an important contributor to graft dysfunction and graft loss after renal transplantation. It has been widely accepted that emergence of BK virus correlates with the more potent immunosuppressive agents currently used to lower acute rejection rates. In contrast to other opportunistic infections after transplantation, for which routine prophylactic agents are administered, there is no effective agent for the prevention of BK infection, nor is there an effective agent for treating BK infection once it occurs.\n\nCiprofloxacin is a well known anti-infective agent in the fluoroquinolone class of antibiotics. It is most active against gram-negative enteric pathogens, and is commonly used for a variety of infectious indications.\n\nThough classified as antibacterial agents, fluoroquinolones have been suggested to exhibit anti-BK viral effects by interfering with helicase activity of the BK virus large T antigen. Ciprofloxacin has been shown in previous studies to reduce urine BK viral load, and BK-associated hemorrhagic cystitis in the stem cell transplant population. Ciprofloxacin has also been associated with a lower incidence of BK viremia in one retrospective study in kidney transplant recipients. Based on these reports, the investigators hope to find a reduction BK viremia and BK nephropathy using a prospective, randomized study design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects over the age of 18 years\n* Recipients of a primary or repeat renal allograft either alone (from a deceased or living donor) or as a dual-kidney transplant\n* Signed informed consent form prior to any research assessment\n\nExclusion Criteria:\n\n* Patients with known severe allergy to ciprofloxacin\n* History of tendon rupture or tendinitis\n* Use of antiarrythmic drugs known to prolong the QT interval such as class IA antiarrhythmic drugs (e.g. quinidine, procainamide, disopyramide), class III antiarrhythmic drugs (e.g. amiodarone, sotalol)\n* Patients with history of previous non-renal transplantation\n* Recipients administered rituximab within one year prior to transplantation, or recipients expected to receive rituximab as part of desensitization strategy or for the presence of historical donor specific antibodies\n* QTc interval interval of greater than 500 msec on admission or post-operative EKG\n* BK nephropathy with previous transplant\n* BK viremia on admission\n* Any condition present during the initial transplant hospitalization that in the investigator's judgment would increase the risk associated with participation in the study"}, 'identificationModule': {'nctId': 'NCT01789203', 'briefTitle': 'Ciprofloxacin for Prevention of BK Infection', 'organization': {'class': 'OTHER', 'fullName': 'The Methodist Hospital Research Institute'}, 'officialTitle': 'Ciprofloxacin for Prevention of BK Infection in Renal Transplant Recipients', 'orgStudyIdInfo': {'id': 'Pro00007510'}, 'secondaryIdInfos': [{'id': 'IRB0612-0114', 'type': 'OTHER', 'domain': 'HMRI IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ciprofloxacin', 'description': 'Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant', 'interventionNames': ['Drug: Ciprofloxacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Ciprofloxacin', 'type': 'DRUG', 'otherNames': ['Cipro'], 'description': 'Patients will be randomized 2:1 active comparator, Cipro, to placebo comparator.', 'armGroupLabels': ['Ciprofloxacin']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['inactive drug', 'innocuous medication'], 'description': 'Patients will be randomized 2:1 placebo comparator to active comparator, Cipro.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Samir J Patel, Pharm.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Pharmacist'}, {'name': 'Ahmed O Gaber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director, Houston Methodist Transplant Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Houston Methodist Transplant Center', 'investigatorFullName': 'Ahmed Osama Gaber, MD', 'investigatorAffiliation': 'The Methodist Hospital Research Institute'}}}}