Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 3:06 AM
Study NCT ID:
NCT01799356
Status:
COMPLETED
Last Update Posted:
2013-08-28
First Post:
2013-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Multicenter Randomized Controlled Trials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000292', 'term': 'Pelvic Inflammatory Disease'}], 'ancestors': [{'id': 'D034161', 'term': 'Pelvic Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D000077266', 'term': 'Moxifloxacin'}, {'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D008795', 'term': 'Metronidazole'}], '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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1303}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-27', 'studyFirstSubmitDate': '2013-02-16', 'studyFirstSubmitQcDate': '2013-02-23', 'lastUpdatePostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinically cure', 'timeFrame': '21 Days'}], 'secondaryOutcomes': [{'measure': 'Microbiological cure', 'timeFrame': '21 Days'}]}, 'conditionsModule': {'keywords': ['Treatment, moksifloksasin'], 'conditions': ['Pelvic Inflammatory Disease']}, 'referencesModule': {'references': [{'pmid': '20716255', 'type': 'RESULT', 'citation': 'Judlin P, Liao Q, Liu Z, Reimnitz P, Hampel B, Arvis P. Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study. BJOG. 2010 Nov;117(12):1475-84. doi: 10.1111/j.1471-0528.2010.02687.x. Epub 2010 Aug 18.'}, {'pmid': '20215625', 'type': 'RESULT', 'citation': 'Boothby M, Page J, Pryor R, Ross JD. A comparison of treatment outcomes for moxifloxacin versus ofloxacin/metronidazole for first-line treatment of uncomplicated non-gonococcal pelvic inflammatory disease. Int J STD AIDS. 2010 Mar;21(3):195-7. doi: 10.1258/ijsa.2009.009374.'}, {'pmid': '32820536', 'type': 'DERIVED', 'citation': 'Savaris RF, Fuhrich DG, Maissiat J, Duarte RV, Ross J. Antibiotic therapy for pelvic inflammatory disease. Cochrane Database Syst Rev. 2020 Aug 20;8(8):CD010285. doi: 10.1002/14651858.CD010285.pub3.'}]}, 'descriptionModule': {'briefSummary': 'We aimed to compare efficacy and safety of combination therapy with oral ofloxacin, 400 mg twice daily, plus oral metronidazole, 500 mg twice daily, for 14 days, with moxifloxacin monotherapy, 400 mg once daily, for 14 days'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women diagnosed uncomplicated PID\n2. Patients age are between 14 with 45\n3. Pelvic tenderness and vaginal discharge\n\nExclusion Criteria:\n\n1. Urinary Tract Enfections\n2. Tubo-ovarian abscess and complicated PID\n3. Hıstory of antibiotics treatment\n4. Other pelvic pain causes\n5. Endometriosis\n6. Delivery,abortion and surgery within last months'}, 'identificationModule': {'nctId': 'NCT01799356', 'briefTitle': 'Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Multicenter Randomized Controlled Trials', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Bakirkoy Maternity and Children Diseases Hospital'}, 'orgStudyIdInfo': {'id': 'Asicioglu03'}, 'secondaryIdInfos': [{'id': 'treatment', 'type': 'OTHER', 'domain': 'treatment pelvic inflammatuary disease'}, {'id': 'treatment uPID', 'type': 'OTHER', 'domain': 'we aimed this study treatment uPID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'moxifloxacin Group', 'description': 'Treatment at uPID with moxifloxacin', 'interventionNames': ['Drug: Moxifloxacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Ofloxacin Group', 'description': 'Treatment at uPID with Ofloxacin plus metronidazole', 'interventionNames': ['Drug: Ofloxacin', 'Drug: Metronidazole']}], 'interventions': [{'name': 'Moxifloxacin', 'type': 'DRUG', 'otherNames': ['new generetaion flouroquinolon antibiotics'], 'description': 'daily 400 mg moksifloksasin', 'armGroupLabels': ['moxifloxacin Group']}, {'name': 'Ofloxacin', 'type': 'DRUG', 'otherNames': ['floroquinolon antibiotics'], 'description': 'daily 800 mg oflaksasin plus 1000 mg metronidazol treatment', 'armGroupLabels': ['Ofloxacin Group']}, {'name': 'Metronidazole', 'type': 'DRUG', 'otherNames': ['anaerobic antibiotics'], 'description': 'daily 1000 mg metronidazol plus 800 mg oflaksasin treatment for uPID', 'armGroupLabels': ['Ofloxacin Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34180', 'city': 'Samatya', 'state': 'Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'T.C.S.B. İstanbul Training Research Hospital', 'geoPoint': {'lat': 41.0, 'lon': 28.93333}}, {'zip': '34280', 'city': 'Istanbul', 'state': 'Kucukcekmece', 'country': 'Turkey (Türkiye)', 'facility': 'T.C.S.B. Kanuni Sultan Suleyman Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '47000', 'city': 'Mardin', 'state': 'Mardin', 'country': 'Turkey (Türkiye)', 'facility': 'T.C.S.B Mardin Women and Children Hospital', 'geoPoint': {'lat': 37.31309, 'lon': 40.74357}}, {'zip': '34150', 'city': 'Şişli', 'state': 'Şişli', 'country': 'Turkey (Türkiye)', 'facility': 'T.C.S.B. Şişli Etfal Training Research Hospital', 'geoPoint': {'lat': 41.06046, 'lon': 28.98717}}], 'overallOfficials': [{'name': 'Kemal Gungorduk, md', 'role': 'STUDY_CHAIR', 'affiliation': 'T.C.S.B. Kanıni Sultan Suleyman Training Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Bakirkoy Maternity and Children Diseases Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Istanbul Sisli Etfal Training Research Hospital', 'investigatorFullName': 'Osman Aşıcıoğlu', 'investigatorAffiliation': 'Istanbul Bakirkoy Maternity and Children Diseases Hospital'}}}}