Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-25 @ 7:51 PM
Study NCT ID:
NCT03400735
Status:
UNKNOWN
Last Update Posted:
2018-01-17
First Post:
2016-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077525', 'term': 'Cefdinir'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-09', 'studyFirstSubmitDate': '2016-10-03', 'studyFirstSubmitQcDate': '2018-01-09', 'lastUpdatePostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The comparison of clinical success rates according to laboratory parameters', 'timeFrame': '7-10 days'}], 'secondaryOutcomes': [{'measure': 'The comparison of remission or relief of inflammation according to laboratory parameters', 'timeFrame': '7-10 days'}, {'measure': 'The comparison of patient satisfaction according to satisfaction questionnaire', 'timeFrame': '7-10 days'}, {'measure': 'The comparison of adverse events', 'timeFrame': '7-10 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Exacerbation of Chronic Bronchitis', 'Community-Acquired Pneumoniae']}, 'descriptionModule': {'briefSummary': 'It is planned to compare the efficacy and safety of cefdinir and cefdinir/clavulanic acide treatments in acute exacerbation of chronic bronchitis (AECB) and community-acquired pneumoniae (CAP) patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The diagnosis of chronic bronchitis\n* The diagnosis of community-acquired pneumoniae\n* FEV1 value = 30-80%\n* The diagnosis of mild-severe acute exacerbation of chronic bronchitis (AECB)\n* Oxygen saturation \\< 90%\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Allergy against to penicillin or cephalosporins\n* Renal impairment\n* Active hepatic disease\n* Antibiotic use except study drugs\n* Immunosuppressive therapy before 6 months of study initiation\n* Use of probenecid like drugs'}, 'identificationModule': {'nctId': 'NCT03400735', 'briefTitle': 'Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neutec Ar-Ge San ve Tic A.Ş'}, 'officialTitle': 'Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Treatment of Acute Exacerbation of Chronic Bronchitis (AECB) and Community-acquired Pneumonia (CAP) in Adults', 'orgStudyIdInfo': {'id': 'NEU-08.16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets', 'interventionNames': ['Drug: Cefdinir 300Mg Capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cefdinir 300 mg Capsules', 'interventionNames': ['Combination Product: Cefdinir/clavulanic acide 300/125 mg film-coated tablets']}], 'interventions': [{'name': 'Cefdinir/clavulanic acide 300/125 mg film-coated tablets', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Fullcef Plus'], 'description': 'Cefdinir is already an approved drug. In this study, developed cefdinir/clavulanic acide combination will be compared against to cefdinir alone.', 'armGroupLabels': ['Cefdinir 300 mg Capsules']}, {'name': 'Cefdinir 300Mg Capsule', 'type': 'DRUG', 'description': 'Cefdinir is used as comparator', 'armGroupLabels': ['Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Erzincan', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Edhem Ünver, Assoc Prof', 'role': 'CONTACT'}, {'name': 'Edhem Ünver, Assoc Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Erzincan University Mengücek Gazi Training and Research Hospital', 'geoPoint': {'lat': 39.73919, 'lon': 39.49015}}, {'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sedat Altın, Prof Dr', 'role': 'CONTACT'}, {'name': 'Sedat Altın, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gülşah Günlüoğlu, Assoc Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nurdan Kalkan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Yedikule Chest Diseases Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Neutec R&D', 'role': 'CONTACT', 'email': 'iremkaraman@neutecrdc.com', 'phone': '00902128505102'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neutec Ar-Ge San ve Tic A.Ş', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}