Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT00194532
Status:
COMPLETED
Last Update Posted:
2014-06-10
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cefpodoxime vs Ciprofloxacin for Acute Cystitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097623', 'term': 'Cefpodoxime'}, {'id': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stapl@uw.edu', 'phone': '206-616-4121', 'title': 'Ann Stapleton, MD', 'organization': 'University Of Washington'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin 250 mg BID X 3 days', 'otherNumAtRisk': 137, 'otherNumAffected': 41, 'seriousNumAtRisk': 150, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cefpodoxime', 'description': 'Cefpodoxime 100 mg BID X 3 days', 'otherNumAtRisk': 137, 'otherNumAffected': 37, 'seriousNumAtRisk': 150, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'gastrointestinal(GI) side effects', 'notes': 'nausea, vomiting, loose stools, abdominal discomfort, other GI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 30, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 26, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'central nervous system (CNS) side effect', 'notes': 'headache, dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vaginal side effects', 'notes': 'vaginal discomfort, discharge, itching, or self-diagnosed yeast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'notes': 'included under GI side effects', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'loose stools', 'notes': 'included under GI side effects', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal discomfort', 'notes': 'included under GI side effects', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'notes': 'included under CNS side effects', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin 250 mg BID X 3 days'}, {'id': 'OG001', 'title': 'Cefpodoxime', 'description': 'Cefpodoxime 100 mg BID X 3 days'}], 'classes': [{'title': 'Cure', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}]}, {'title': 'Not cure', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28-30 days post therapy', 'description': 'Participants with clinical cure, i.e. free of urinary tract symptoms and requiring no further antibiotic treatment, to assess the efficacy of a 3-day regimen of cefpodoxime compared to ciprofloxacin', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'modified ITT'}, {'type': 'SECONDARY', 'title': 'Microbiologic Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin 250 mg BID X 3 days'}, {'id': 'OG001', 'title': 'Cefpodoxime', 'description': 'Cefpodoxime 100 mg BID X 3 days'}], 'classes': [{'title': 'Cure', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}, {'title': 'Not cure', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-15 days post therapy', 'description': 'Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol. Participants were eligible for analysis if they had an enrollment urine containing uropathogens and a urine specimen taken at follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin 250 mg BID X 3 days'}, {'id': 'FG001', 'title': 'Cefpodoxime', 'description': 'Cefpodoxime 100 mg BID X 3 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ciprofloxacin', 'description': 'Ciprofloxacin 250 mg BID X 3 days'}, {'id': 'BG001', 'title': 'Cefpodoxime', 'description': 'Cefpodoxime 100 mg BID X 3 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '55'}, {'value': '23', 'groupId': 'BG001', 'lowerLimit': '17', 'upperLimit': '44'}, {'value': '24', 'groupId': 'BG002', 'lowerLimit': '17', 'upperLimit': '55'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-03', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2011-03-30', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-30', 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Cure', 'timeFrame': '28-30 days post therapy', 'description': 'Participants with clinical cure, i.e. free of urinary tract symptoms and requiring no further antibiotic treatment, to assess the efficacy of a 3-day regimen of cefpodoxime compared to ciprofloxacin'}], 'secondaryOutcomes': [{'measure': 'Microbiologic Cure', 'timeFrame': '1-15 days post therapy', 'description': 'Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['UTI'], 'conditions': ['Urinary Tract Infection']}, 'referencesModule': {'references': [{'pmid': '22318279', 'type': 'RESULT', 'citation': 'Hooton TM, Roberts PL, Stapleton AE. Cefpodoxime vs ciprofloxacin for short-course treatment of acute uncomplicated cystitis: a randomized trial. JAMA. 2012 Feb 8;307(6):583-9. doi: 10.1001/jama.2012.80.'}]}, 'descriptionModule': {'briefSummary': 'Urinary tract infection (UTI) is a very common problem in young healthy women, afflicting approximately one-half of women by their late 20s. One of the most common antibiotics used to treat UTIs is ciprofloxacin, usually for a total of three days. However, increasing resistance to this antibiotic has raised concerns about its overuse for cystitis and generated interest in alternative agents. An alternative antibiotic which is approved for use in UTIs is cefpodoxime. However, there are few studies evaluating the efficacy and tolerance of this compound when given in a 3-day regimen as is commonly used for treatment of UTI. The major purpose of this study is to assess the efficacy and tolerance of a 3-day regimen of cefpodoxime versus ciprofloxacin for treatment of acute uncomplicated cystitis.', 'detailedDescription': 'Procedures subjects will undergo once they have read and signed the consent are:\n\nQuestions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine and peri-urethral sample and then are randomly assigned to one of the two treatment groups.They will be given a sheet to record symptoms at home. They will be asked to return to the clinic in 5-9 and 28-30 days after completing antibiotic therapy.Follow-up questions will be asked and urine and peri-urethral will be self collected at each visit.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nonpregnant females in good general health with symptoms of acute cystitis\n\nExclusion Criteria:\n\n* Pregnant,lactating, or not regularly contracepting: known anatomic abnormalities of the urinary tract; use of prophylactic antibiotics; history of allergy or intolerance to any of the study drugs; recent (\\>2 weeks)exposure to an oral or parenteral antimicrobial; or history of UTI in the previous 1 month'}, 'identificationModule': {'nctId': 'NCT00194532', 'briefTitle': 'Cefpodoxime vs Ciprofloxacin for Acute Cystitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Cefpodoxime vs Ciprofloxacin for Acute Cystitis', 'orgStudyIdInfo': {'id': '27085-D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cefpodoxime', 'description': 'Cefpodoxime 100mg twice a day(BID)for 3 days', 'interventionNames': ['Drug: Cefpodoxime']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ciprofloxacin', 'description': 'Ciprofloxacin 250mg twice a day (BID)for 3 days', 'interventionNames': ['Drug: Ciprofloxacin']}], 'interventions': [{'name': 'Cefpodoxime', 'type': 'DRUG', 'description': 'Cefpodoxime 100mg twice a day(BID)for 3 days', 'armGroupLabels': ['Cefpodoxime']}, {'name': 'Ciprofloxacin', 'type': 'DRUG', 'description': 'Ciprofloxacin 250mg twice a day (BID)for 3 days', 'armGroupLabels': ['Ciprofloxacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Ann Stapleton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington, Department of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ann Stapleton', 'investigatorAffiliation': 'University of Washington'}}}}