Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT00334633
Status:
COMPLETED
Last Update Posted:
2017-12-02
First Post:
2006-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Bacterial Vaginosis (BV) With Tinidazole
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016585', 'term': 'Vaginosis, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014011', 'term': 'Tinidazole'}, {'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'schwebke@uab.edu', 'phone': '205-975-5665', 'title': 'jane R Schwebke, MD', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Metronidazole', 'description': 'metronidazole 500 BID for 7 days; 197 participants', 'otherNumAtRisk': 197, 'otherNumAffected': 87, 'seriousNumAtRisk': 197, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tinidazole 500 mg', 'description': 'tinidazole 500 BID for 7 days; 200 particpants', 'otherNumAtRisk': 200, 'otherNumAffected': 109, 'seriousNumAtRisk': 200, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Tinidazole 1 gm', 'description': 'tinidazole 1 gm BID for 7 days; 196 particpants', 'otherNumAtRisk': 196, 'otherNumAffected': 145, 'seriousNumAtRisk': 196, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'vaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 39, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 54, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 91, 'numAffected': 91}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cure of Bacterial Vaginosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Metronidazole', 'description': 'metronidazole 500 BID for 7 days; 197 participants'}, {'id': 'OG001', 'title': 'Tinidazole 500 mg', 'description': 'tinidazole 500 BID for 7 days; 200 particpants'}, {'id': 'OG002', 'title': 'Tinidazole 1 gm', 'description': 'tinidazole 1 gm BID for 7 days; 196 particpants'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one month', 'description': 'resolution of Amsel criteria for bacterial vaginosis', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Recurrence of BV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'metronidazole 500 BID for 7 days\n\ntinidazole, metronidazole: Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid'}, {'id': 'OG001', 'title': 'Tinidazole 500', 'description': 'tinidazole 500 BID for 7 days\n\ntinidazole, metronidazole: Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid'}, {'id': 'OG002', 'title': 'Tinidazole 1 gm', 'description': 'tinidazole 1 gm BID for 7 days\n\ntinidazole, metronidazole: Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline to 4 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metronidazole', 'description': 'metronidazole 500 twice a day (BID) for 7 days; 197 participants'}, {'id': 'FG001', 'title': 'Tinidazole 500 mg', 'description': 'tinidazole 500 BID for 7 days; 200 particpants'}, {'id': 'FG002', 'title': 'Tinidazole 1 gm', 'description': 'tinidazole 1 gm BID for 7 days; 196 particpants'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '200'}, {'groupId': 'FG002', 'numSubjects': '196'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '118'}, {'groupId': 'FG002', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '82'}]}]}], 'recruitmentDetails': 'women attending a sexually transmitted disease (STD) clinic with symptomatic bacterial vaginosis (BV)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}, {'value': '593', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Metronidazole', 'description': 'metronidazole 500 BID for 7 days; 197 participants'}, {'id': 'BG001', 'title': 'Tinidazole 500 mg', 'description': 'tinidazole 500 BID for 7 days; 200 particpants'}, {'id': 'BG002', 'title': 'Tinidazole 1 gm', 'description': 'tinidazole 1 gm BID for 7 days; 196 particpants'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}, {'value': '593', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '28.3', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '28.5', 'spread': '6.8', 'groupId': 'BG002'}, {'value': '28.3', 'spread': '6.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}, {'value': '593', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}, {'value': '593', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 593}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-26', 'studyFirstSubmitDate': '2006-06-07', 'resultsFirstSubmitDate': '2011-03-03', 'studyFirstSubmitQcDate': '2006-06-07', 'lastUpdatePostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-05-24', 'studyFirstPostDateStruct': {'date': '2006-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cure of Bacterial Vaginosis', 'timeFrame': 'one month', 'description': 'resolution of Amsel criteria for bacterial vaginosis'}], 'secondaryOutcomes': [{'measure': 'Recurrence of BV', 'timeFrame': 'baseline to 4 weeks'}]}, 'conditionsModule': {'keywords': ['bacterial vaginosis', 'tinidazole'], 'conditions': ['Bacterial Vaginosis']}, 'descriptionModule': {'briefSummary': 'We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than treatment with metronidazole', 'detailedDescription': 'Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV). Control of BV has been advocated as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates. Although not currently licensed in the U.S., tinidazole is an antimicrobial related to metronidazole which has shown promise for the treatment of BV in European studies and is widely used worldwide for the treatment of trichomoniasis including infections which are resistant to metronidazole. We hypothesize that qualities of tinidazole such as its longer half-life and its seemingly superior side effect profile as compared to oral metronidazole will result in its being a more efficacious drug for the treatment of BV than the currently available options.\n\nThe specific aims of this project are:\n\n1. To compare the efficacy of two different doses of tinidazole with oral metronidazole for the initial treatment of symptomatic BV as well as short-term recurrence rates\n2. To compare the side effect profiles of tinidazole versus metronidazole in the treatment of BV\n3. To compare drug levels of tinidazole and metronidazole in the vaginal secretions and correlate with microbiologic cure of BV as well as rates of recurrence.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women be at least 18 years of age\n* Have symptoms of vaginal odor and or/discharge\n* Meet the clinical (Amsel) criteria for BV\n* Willing to participate in research\n\nExclusion Criteria:\n\n* Presence of another vaginal infection or STD\n* Allergy to metronidazole\n* Pregnant or nursing\n* Use of oral or intravaginal antibiotics within the past 2 weeks\n* HIV or other chronic disease\n* Inability to keep return appointments'}, 'identificationModule': {'nctId': 'NCT00334633', 'briefTitle': 'Treatment of Bacterial Vaginosis (BV) With Tinidazole', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Tinidazole for the Treatment of Bacterial Vaginosis', 'orgStudyIdInfo': {'id': 'F040329003'}, 'secondaryIdInfos': [{'id': 'R01AI058033', 'link': 'https://reporter.nih.gov/quickSearch/R01AI058033', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'metronidazole 500 BID for 7 days', 'interventionNames': ['Drug: tinidazole, metronidazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tinidazole 500', 'description': 'tinidazole 500 BID for 7 days', 'interventionNames': ['Drug: tinidazole, metronidazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tinidazole 1 gm', 'description': 'tinidazole 1 gm BID for 7 days', 'interventionNames': ['Drug: tinidazole, metronidazole']}], 'interventions': [{'name': 'tinidazole, metronidazole', 'type': 'DRUG', 'otherNames': ['Tindamax, Flagyl'], 'description': 'Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid', 'armGroupLabels': ['control', 'tinidazole 1 gm', 'tinidazole 500']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Jefferson County Department of Health STD Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Jane Schwebke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jane Schwebke', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}