Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 6:48 AM
Study NCT ID:
NCT01297894
Status:
UNKNOWN
Last Update Posted:
2011-12-29
First Post:
2011-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colistin Versus Colistin Plus Fosfomycin for Infections Caused by MDR Acinetobacter Baumannii
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003091', 'term': 'Colistin'}, {'id': 'D005578', 'term': 'Fosfomycin'}], 'ancestors': [{'id': 'D011113', 'term': 'Polymyxins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D023181', 'term': 'Antimicrobial Cationic Peptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000089882', 'term': 'Antimicrobial Peptides'}, {'id': 'D052899', 'term': 'Pore Forming Cytotoxic Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-24', 'studyFirstSubmitDate': '2011-02-15', 'studyFirstSubmitQcDate': '2011-02-16', 'lastUpdatePostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of subjects with cure or improvement', 'timeFrame': 'up to 28days', 'description': 'cure improvement worse death'}], 'secondaryOutcomes': [{'measure': 'number of subjects with eradication of causative bacteria', 'timeFrame': 'up to 28days', 'description': 'eradication persistence superinfection'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['A. baumannii', 'colistin', 'fosfomycin'], 'conditions': ['Drug Safety']}, 'referencesModule': {'references': [{'pmid': '24982065', 'type': 'DERIVED', 'citation': 'Sirijatuphat R, Thamlikitkul V. Preliminary study of colistin versus colistin plus fosfomycin for treatment of carbapenem-resistant Acinetobacter baumannii infections. Antimicrob Agents Chemother. 2014 Sep;58(9):5598-601. doi: 10.1128/AAC.02435-13. Epub 2014 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'In Siriraj Hospital, colistin alone for treatment of MDR A. baumannii contributed to mortality 45% Fosfomycin is an antimicrobial which has activity against gram-negative bacterial including MDR A. baumannii In this study, we compare the clinical and microbiologicalresponse of colistin alone versus colistin plus fosfomycin in treatment of A. baumannii infected patients', 'detailedDescription': 'Inclusion criteria\n\n* Age\\> 18 years\n* Hospitalized to Siriraj Hospital\n* Infected caused by A. baumannii\n* Need Colistin treatment\n\nExclusion criteria\n\n* Pregnancy or Lactating mother\n* Colistin or Fosfomycin Allergy\n* Patients who have severe abnormal renal or liver function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\> 18 years\n* Hospitalized to Siriraj Hospital\n* Infected caused by A. baumannii\n* Need Colistin treatment\n\nExclusion criteria:\n\n* Pregnancy or Lactating mother\n* Colistin or Fosfomycin Allergy\n* Patients who have severe abnormal renal or liver function'}, 'identificationModule': {'nctId': 'NCT01297894', 'briefTitle': 'Colistin Versus Colistin Plus Fosfomycin for Infections Caused by MDR Acinetobacter Baumannii', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Colistin Plus Fosfomycin in Multi-Drug Resistant Acinetobacter Baumannii', 'orgStudyIdInfo': {'id': 'Siriraj CEU53-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'colistin', 'description': 'Colistimethate sodium 2.5-5mg/kg iv', 'interventionNames': ['Drug: colistin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'colistin plus fosfomycin', 'description': 'colistimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours', 'interventionNames': ['Drug: colistin plus fosfomycin']}], 'interventions': [{'name': 'colistin', 'type': 'DRUG', 'otherNames': ['Colistate'], 'description': 'Colistimethate sodium 2.5-5mg/kg of colistin base', 'armGroupLabels': ['colistin']}, {'name': 'colistin plus fosfomycin', 'type': 'DRUG', 'otherNames': ['Colistate', 'Fosmicin'], 'description': 'colitimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours', 'armGroupLabels': ['colistin plus fosfomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Dr. Visanu Thamlikitkul, Professor', 'role': 'CONTACT', 'email': 'sivth@mahidol.ac.th', 'phone': '662-419-6626'}, {'name': 'Dr. Pornpan Koomanachai, MD', 'role': 'CONTACT', 'email': 'nokmed@yahoo.com', 'phone': '662-419-7783'}, {'name': 'Dr. Pornpan Koomanachai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Dr Visanu Thamlikitkul, Professor', 'role': 'CONTACT', 'email': 'sivth@mahidol.ac.th', 'phone': '662-419-6626'}, {'name': 'Dr Pornpan Koomanachai, MD', 'role': 'CONTACT', 'email': 'nokmed@yahoo.com', 'phone': '662-419-7783'}], 'overallOfficials': [{'name': 'Visanu Thamlikitkul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division of Infectious Diseases and tropical medicine, Department of medicine, Faculty of Medicine Siriraj Hospital.', 'investigatorFullName': 'Visanu Thamlikitkul', 'investigatorAffiliation': 'Mahidol University'}}}}