Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-26 @ 11:08 PM
Study NCT ID:
NCT00405704
Status:
COMPLETED
Last Update Posted:
2020-04-21
First Post:
2006-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D014718', 'term': 'Vesico-Ureteral Reflux'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015662', 'term': 'Trimethoprim, Sulfamethoxazole Drug Combination'}], 'ancestors': [{'id': 'D013420', 'term': 'Sulfamethoxazole'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014295', 'term': 'Trimethoprim'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'myra_carpenter@unc.edu', 'phone': '919-962-3245', 'title': 'Dr. Myra Carpenter, Senior Investigator', 'organization': 'UNC Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Results may not apply to children with different demographic or clinical characteristics or in locales where choice of TMP-SMZ may be limited by susceptibility patterns or clinical acceptability. Some subgroup analyses had limited statistical power.'}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Trimethoprim-Sulfamethoxazole', 'description': 'Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.', 'otherNumAtRisk': 302, 'otherNumAffected': 79, 'seriousNumAtRisk': 302, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo: Cherry flavored liquid suspension matched to active comparator.', 'otherNumAtRisk': 305, 'otherNumAffected': 105, 'seriousNumAtRisk': 305, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numEvents': 58, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 305, 'numEvents': 80, 'numAffected': 55}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 305, 'numEvents': 33, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 305, 'numEvents': 20, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numEvents': 30, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 305, 'numEvents': 26, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 305, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 305, 'numEvents': 27, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trimethoprim-Sulfamethoxazole', 'description': 'Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Cherry flavored liquid suspension matched to active comparator.'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Outcome Renal Scarring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trimethoprim-Sulfamethoxazole', 'description': 'Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Cherry flavored liquid suspension matched to active comparator.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Renal scarring was defined as a decreased uptake of tracer that was associated with loss of contours or the presence of cortical thinning. Outcome dimercaptosuccinic acid (DMSA) scan was performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population excluded 75 subjects in the trimethoprim-sulfamethoxazole group and 70 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.'}, {'type': 'SECONDARY', 'title': 'Severe Renal Scarring on Outcome Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trimethoprim-Sulfamethoxazole', 'description': 'Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Cherry flavored liquid suspension matched to active comparator.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Severe renal scarring was defined as scarring in more than 4 of 12 segments in at least one kidney or global atrophy characterized by diffusely scarred and shrunken kidney. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population excluded 75 subjects in the trimethoprim-sulfamethoxazole group and 70 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.'}, {'type': 'SECONDARY', 'title': 'New Renal Scarring on Outcome Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trimethoprim-Sulfamethoxazole', 'description': 'Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Cherry flavored liquid suspension matched to active comparator.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'New renal scarring was defined as scarring on the outcome renal scan with technetium -99m-labeled dimercaptosuccinic acid that was not present at baseline. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population excluded 82 subjects in the trimethoprim-sulfamethoxazole group and 78 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.'}, {'type': 'SECONDARY', 'title': 'Treatment Failure Composite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trimethoprim-Sulfamethoxazole', 'description': 'Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Cherry flavored liquid suspension matched to active comparator.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Treatment failure was defined as the occurrence of two febrile urinary tract infections (UTIs), one febrile UTI and three symptomatic UTIs, four symptomatic UTIs, or new or worsening renal scarring on an interim scan (e.g,, the 12-month visit); renal scans from the 2-year visit are NOT considered in the treatment failure criteria.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trimethoprim-Sulfamethoxazole', 'description': 'Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Cherry flavored liquid suspension matched to active comparator.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.065', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population excluded 99 subjects in the trimethoprim-sulfamethoxazole group and 95 subjects in the placebo group who did not have stool analyzed at the outcome visit.'}, {'type': 'SECONDARY', 'title': 'Recurrent Febrile or Symptomatic UTI With Resistant E. Coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trimethoprim-Sulfamethoxazole', 'description': 'Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Cherry flavored liquid suspension matched to active comparator.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is restricted to the 30 subjects in the trimethoprim-sulfamethoxazole (TMP-SMZ) group and 57 subjects in the placebo group who had a recurrent UTI with E. coli for which sensitivity to TMP-SMZ was assessed.'}, {'type': 'SECONDARY', 'title': 'Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trimethoprim-Sulfamethoxazole', 'description': 'Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Cherry flavored liquid suspension matched to active comparator.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is restricted to the 38 subjects in the trimethoprim-sulfamethoxazole (TMP-SMZ) group and 69 subjects in the placebo group who had a recurrent UTI with an organism for which sensitivity to TMP-SMZ was assessed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trimethoprim-Sulfamethoxazole', 'description': 'Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo: Cherry flavored liquid suspension matched to active comparator.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '302'}, {'groupId': 'FG001', 'numSubjects': '305'}]}, {'type': 'Completed Outcome Renal Scan', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}, {'groupId': 'FG001', 'numSubjects': '235'}]}, {'type': 'Completed Assessments for New Scarring', 'achievements': [{'groupId': 'FG000', 'numSubjects': '220'}, {'groupId': 'FG001', 'numSubjects': '227'}]}, {'type': 'Outcome Stool Assessed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '210'}]}, {'type': 'Recurrent UTI With E. Coli', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'Recurrent UTI With TMP-SMZ Panel', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '261'}, {'groupId': 'FG001', 'numSubjects': '259'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '46'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'BG000'}, {'value': '305', 'groupId': 'BG001'}, {'value': '607', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Trimethoprim-Sulfamethoxazole', 'description': 'Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo: Cherry flavored liquid suspension matched to active comparator.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '31'}, {'value': '12', 'groupId': 'BG001', 'lowerLimit': '6', 'upperLimit': '30'}, {'value': '12', 'groupId': 'BG002', 'lowerLimit': '6', 'upperLimit': '31'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '277', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '558', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '305', 'groupId': 'BG001'}, {'value': '607', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 607}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-13', 'studyFirstSubmitDate': '2006-11-29', 'resultsFirstSubmitDate': '2014-12-04', 'studyFirstSubmitQcDate': '2006-11-29', 'lastUpdatePostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-04-15', 'studyFirstPostDateStruct': {'date': '2006-11-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Outcome Renal Scarring', 'timeFrame': '2 years', 'description': 'Renal scarring was defined as a decreased uptake of tracer that was associated with loss of contours or the presence of cortical thinning. Outcome dimercaptosuccinic acid (DMSA) scan was performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.'}, {'measure': 'Severe Renal Scarring on Outcome Scan', 'timeFrame': '2 years', 'description': 'Severe renal scarring was defined as scarring in more than 4 of 12 segments in at least one kidney or global atrophy characterized by diffusely scarred and shrunken kidney. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.'}, {'measure': 'New Renal Scarring on Outcome Scan', 'timeFrame': '2 years', 'description': 'New renal scarring was defined as scarring on the outcome renal scan with technetium -99m-labeled dimercaptosuccinic acid that was not present at baseline. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.'}, {'measure': 'Treatment Failure Composite', 'timeFrame': '2 years', 'description': 'Treatment failure was defined as the occurrence of two febrile urinary tract infections (UTIs), one febrile UTI and three symptomatic UTIs, four symptomatic UTIs, or new or worsening renal scarring on an interim scan (e.g,, the 12-month visit); renal scans from the 2-year visit are NOT considered in the treatment failure criteria.'}, {'measure': 'Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)', 'timeFrame': '2 years'}, {'measure': 'Recurrent Febrile or Symptomatic UTI With Resistant E. Coli', 'timeFrame': '2 years'}, {'measure': 'Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vesicoureteral Reflux', 'Urinary Tract Infections', 'Renal Scarring', 'Antibiotic Resistance', 'Controlled Clinical Trial', 'Trimethoprim-Sulfamethoxazole', 'Children'], 'conditions': ['Vesicoureteral Reflux', 'Urinary Tract Infections']}, 'referencesModule': {'references': [{'pmid': '19450818', 'type': 'BACKGROUND', 'citation': 'Ziessman HA, Majd M. Importance of methodology on (99m)technetium dimercapto-succinic acid scintigraphic image quality: imaging pilot study for RIVUR (Randomized Intervention for Children With Vesicoureteral Reflux) multicenter investigation. J Urol. 2009 Jul;182(1):272-9. doi: 10.1016/j.juro.2009.02.144. Epub 2009 May 17.'}, {'pmid': '19570724', 'type': 'BACKGROUND', 'citation': 'Mathews R, Carpenter M, Chesney R, Hoberman A, Keren R, Mattoo T, Moxey-Mims M, Nyberg L, Greenfield S. Controversies in the management of vesicoureteral reflux: the rationale for the RIVUR study. J Pediatr Urol. 2009 Oct;5(5):336-41. doi: 10.1016/j.jpurol.2009.05.010. Epub 2009 Jul 1.'}, {'pmid': '19018048', 'type': 'BACKGROUND', 'citation': 'Keren R, Carpenter MA, Hoberman A, Shaikh N, Matoo TK, Chesney RW, Matthews R, Gerson AC, Greenfield SP, Fivush B, McLurie GA, Rushton HG, Canning D, Nelson CP, Greenbaum L, Bukowski T, Primack W, Sutherland R, Hosking J, Stewart D, Elder J, Moxey-Mims M, Nyberg L. Rationale and design issues of the Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) study. Pediatrics. 2008 Dec;122 Suppl 5(Suppl 5):S240-50. doi: 10.1542/peds.2008-1285d.'}, {'pmid': '18076937', 'type': 'BACKGROUND', 'citation': 'Greenfield SP, Chesney RW, Carpenter M, Moxey-Mims M, Nyberg L, Hoberman A, Keren R, Matthews R, Mattoo T. Vesicoureteral reflux: the RIVUR study and the way forward. J Urol. 2008 Feb;179(2):405-7. doi: 10.1016/j.juro.2007.10.100. No abstract available.'}, {'pmid': '19018047', 'type': 'BACKGROUND', 'citation': 'Chesney RW, Carpenter MA, Moxey-Mims M, Nyberg L, Greenfield SP, Hoberman A, Keren R, Matthews R, Matoo TK; members of the RIVUR Steering Committee. Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR): background commentary of RIVUR investigators. Pediatrics. 2008 Dec;122 Suppl 5(0 5):S233-9. doi: 10.1542/peds.2008-1285c.'}, {'pmid': '19086141', 'type': 'BACKGROUND', 'citation': 'Keren R. Pediatrics. RIVUR trial. Introduction. Pediatrics. 2008 Dec;122 Suppl 5:S231-2. doi: 10.1542/peds.2008-1285b. No abstract available.'}, {'pmid': '22910235', 'type': 'BACKGROUND', 'citation': 'Greenfield SP, Carpenter MA, Chesney RW, Zerin JM, Chow J. The RIVUR voiding cystourethrogram pilot study: experience with radiologic reading concordance. J Urol. 2012 Oct;188(4 Suppl):1608-12. doi: 10.1016/j.juro.2012.06.032. Epub 2012 Aug 19.'}, {'pmid': '23546617', 'type': 'BACKGROUND', 'citation': 'Hoberman A, Shaikh N, Bhatnagar S, Haralam MA, Kearney DH, Colborn DK, Kienholz ML, Wang L, Bunker CH, Keren R, Carpenter MA, Greenfield SP, Pohl HG, Mathews R, Moxey-Mims M, Chesney RW. Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters. JAMA Pediatr. 2013 Jun;167(6):561-6. doi: 10.1001/jamapediatrics.2013.1050.'}, {'pmid': '24151147', 'type': 'BACKGROUND', 'citation': 'Bhatnagar S, Hoberman A, Kearney DH, Shaikh N, Moxey-Mims MM, Chesney RW, Carpenter MA, Greenfield SP, Keren R, Mattoo TK, Mathews R, Gravens-Mueller L, Ivanova A. Development and impact of an intervention to boost recruitment in a multicenter pediatric randomized clinical trial. Clin Pediatr (Phila). 2014 Feb;53(2):151-7. doi: 10.1177/0009922813506961. Epub 2013 Oct 22.'}, {'pmid': '23044377', 'type': 'BACKGROUND', 'citation': 'Chesney RW, Patters AB. Childhood vesicoureteral reflux studies: registries and repositories sources and nosology. J Pediatr Urol. 2013 Dec;9(6 Pt A):731-7. doi: 10.1016/j.jpurol.2012.09.003. Epub 2012 Oct 5.'}, {'pmid': '23753091', 'type': 'RESULT', 'citation': 'Carpenter MA, Hoberman A, Mattoo TK, Mathews R, Keren R, Chesney RW, Moxey-Mims M, Greenfield SP; RIVUR Trial Investigators. The RIVUR trial: profile and baseline clinical associations of children with vesicoureteral reflux. Pediatrics. 2013 Jul;132(1):e34-45. doi: 10.1542/peds.2012-2301. Epub 2013 Jun 10.'}, {'pmid': '24795142', 'type': 'RESULT', 'citation': 'RIVUR Trial Investigators; Hoberman A, Greenfield SP, Mattoo TK, Keren R, Mathews R, Pohl HG, Kropp BP, Skoog SJ, Nelson CP, Moxey-Mims M, Chesney RW, Carpenter MA. Antimicrobial prophylaxis for children with vesicoureteral reflux. N Engl J Med. 2014 Jun 19;370(25):2367-76. doi: 10.1056/NEJMoa1401811. Epub 2014 May 4.'}, {'pmid': '28967387', 'type': 'DERIVED', 'citation': 'Primack W, Bukowski T, Sutherland R, Gravens-Mueller L, Carpenter M. What Urinary Colony Count Indicates a Urinary Tract Infection in Children? J Pediatr. 2017 Dec;191:259-261.e1. doi: 10.1016/j.jpeds.2017.08.012. Epub 2017 Sep 28.'}, {'pmid': '26055855', 'type': 'DERIVED', 'citation': 'Keren R, Shaikh N, Pohl H, Gravens-Mueller L, Ivanova A, Zaoutis L, Patel M, deBerardinis R, Parker A, Bhatnagar S, Haralam MA, Pope M, Kearney D, Sprague B, Barrera R, Viteri B, Egigueron M, Shah N, Hoberman A. Risk Factors for Recurrent Urinary Tract Infection and Renal Scarring. Pediatrics. 2015 Jul;136(1):e13-21. doi: 10.1542/peds.2015-0409. Epub 2015 Jun 8.'}], 'seeAlsoLinks': [{'url': 'http://www.rivur.net', 'label': 'RIVUR trial web site'}]}, 'descriptionModule': {'briefSummary': 'In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ) prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial resistance.', 'detailedDescription': 'This multicenter, randomized, double-blind, placebo-controlled trial was designed to determine whether daily antimicrobial prophylaxis is superior to placebo in preventing recurrence of urinary tract infection (UTI) in children with vesicoureteral reflux (VUR). Eligibility criteria are described elsewhere. Patients were randomly assigned to treatment for 2 years with daily antimicrobial prophylaxis (trimethoprim-sulfamethoxazole) or placebo. The study was designed to recruit 600 children (approximately 300 in each treatment group). The protocol encouraged prompt evaluation of children with UTI symptoms and early therapy of culture-proven UTIs. It was expected that approximately 10% of children will have to discontinue study medication due to allergic reactions. Assuming a 20% placebo event rate and 10% non-compliance rate, the study has 83% power to detect an absolute 10% event rate in the antimicrobial prophylaxis group. If the placebo event rate is instead 25%, power is 97% to detect an absolute 10% event rate in the treated group, even if non-compliance is as high as 15%. The primary analysis is intention-to-treat with missing outcome data analyzed as UTI.\n\nIn addition to collecting follow-up data on urinary tract infections, renal scarring and antimicrobial resistance, quality of life, compliance, safety parameters, utilization of health resources, and change in VUR were assessed periodically throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '71 Months', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at randomization: at least 2 months, but less than 6 years of age. Note that children as young as 1 month were screened for the study.\n* Diagnosed first or second febrile or symptomatic UTI within 112 days prior to randomization\n* Presence of Grade I- IV VUR based on radiographic voiding cystourethrogram (VCUG) performed within 112 days of diagnosis of index UTI.\n* Appropriately treated index febrile or symptomatic UTI\n\nExclusion Criteria:\n\n* Index UTI diagnosis more than 112 days prior to randomization\n* History of more than two UTIs prior to randomization\n* For patients less than 6 months of age at randomization, gestational age less than 34 weeks\n* Co-morbid urologic anomalies\n* Hydronephrosis, SFU Grade 4\n* Ureterocele\n* Urethral valve\n* Solitary kidney\n* Profoundly decreased renal size unilaterally on ultrasound (based on 2 standard deviations below the mean for age and length) performed within 112 days after diagnosis of index UTI\n* Multicystic dysplastic kidney\n* Neurogenic bladder\n* Pelvic kidney or fused kidney\n* Known sulfa allergy, inadequate renal or hepatic function, Glucose-6-phosphate dehydrogenase deficiency or other conditions that are contraindications for use of TMP-SMZ\n* History of other renal injury/disease\n* Unable to complete the study protocol\n* Congenital or acquired immunodeficiency\n* Underlying anomalies or chronic diseases that could potentially interfere with response to therapy such as chronic gastrointestinal conditions (i.e., malabsorption, inflammatory bowel disease), liver or kidney failure, or malignancy.\n* Complex cardiac disease as defined in the Manual of Procedures.\n* Any known syndromes associated with VUR or bladder dysfunction\n* Index UTI not successfully treated\n* Unlikely to complete follow-up\n* Family history of anaphylactic reaction to sulfa medications'}, 'identificationModule': {'nctId': 'NCT00405704', 'acronym': 'RIVUR', 'briefTitle': 'Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)', 'orgStudyIdInfo': {'id': 'DK074059 (IND)'}, 'secondaryIdInfos': [{'id': 'U01DK074059', 'link': 'https://reporter.nih.gov/quickSearch/U01DK074059', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Trimethoprim-Sulfamethoxazole', 'description': 'Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.', 'interventionNames': ['Drug: Trimethoprim-Sulfamethoxazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Cherry-flavored liquid suspension matched to active comparator.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Trimethoprim-Sulfamethoxazole', 'type': 'DRUG', 'otherNames': ['Sulfatrim', 'Bactrim'], 'description': 'Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.', 'armGroupLabels': ['Trimethoprim-Sulfamethoxazole']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Cherry flavored liquid suspension matched to active comparator.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Alfred I. duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital of Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '14222', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': "Women and Children's Hospital of Buffalo", 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44308', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': "Akron Children's Hospital", 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': "University of Wisconsin Children's Hospital", 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Sahar Fathallah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama, Birmingham, AL'}, {'name': 'Myra A Carpenter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of NC at Chapel Hill, Chapel Hill, NC'}, {'name': 'Caleb P. Nelson, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Boston, Boston, MA"}, {'name': 'Eileen Brewer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Texas Children's Hospital, Houston, TX"}, {'name': 'Saul P Greenfield, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Women and Children's Hospital of Buffalo, Buffalo, NY"}, {'name': 'Alejandro Hoberman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Pittsburgh, Pittsburgh, PA"}, {'name': 'Ron Keren, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia, Philadelphia, PA"}, {'name': 'Bradley P Kropp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma, Oklahoma City, OK'}, {'name': 'Ranjiv Mathews, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'Tej K Mattoo, MD,DCH, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University School of Medicine, Detroit, MI'}, {'name': 'H. Gil Rushton, MD, FAAP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's National Research Institute"}, {'name': 'Mary Ann Queen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}, {'name': 'Russell W Chesney, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Le Bonheur Children's Medical Center, Memphis, TN"}, {'name': 'Steven J Skoog, MD FACS,FAAP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health & Science University, Portland, OR'}, {'name': 'Amy Renwick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alfred I. duPont Hospital for Children, Wilmington, DE'}, {'name': 'Earl Y. Cheng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL"}, {'name': 'Milan Nadkarni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Baptist Medical Center, Winston-Salem, NC'}, {'name': 'Caleb P Nelson, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Boston, Boston, MA"}, {'name': 'William R DeFoor, Jr, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Cincinnati Children's Hospital, Cincinnati, OH"}, {'name': 'Dan McMahon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Akron Children's Hospital, Akron, OH"}, {'name': 'Ross Decter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State Hershey Medical Center, Hershey, PA'}, {'name': 'Sharon M Bartosh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'url': 'https://repository.niddk.nih.gov/studies/rivur/?query=rivur', 'ipdSharing': 'YES', 'description': 'Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/rivur/?query=rivur'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'collaborators': [{'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}