Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
Study NCT ID:
NCT06570850
Status:
RECRUITING
Last Update Posted:
2024-08-26
First Post:
2024-08-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C004691', 'term': 'colistinmethanesulfonic acid'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 188}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2024-08-14', 'studyFirstSubmitQcDate': '2024-08-22', 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with clinical response after completion of therapy', 'timeFrame': 'Baseline, day 10-14 (end of therapy)', 'description': 'Clinical response are categorized as: clinical cure if participants recover all symptoms and signs of infection; partial response if they disappear only some of the initial symptoms and signs of infection, including the condition not fulfilling all the requirements for clinical cure; and clinical failure if participants have persistence or worsening of all symptoms and signs of infection despite antimicrobial treatment.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with clinical response at 72 hours of therapy', 'timeFrame': 'Baseline, day 3', 'description': 'Clinical response are categorized as: clinical cure if participants recover all symptoms and signs of infection; partial response if they disappear only some of the initial symptoms and signs of infection, including the condition not fulfilling all the requirements for clinical cure; and clinical failure if participants have persistence or worsening of all symptoms and signs of infection despite antimicrobial treatment.'}, {'measure': 'Number of participants with microbiological cure at 72 hours of therapy', 'timeFrame': 'Baseline, day 3', 'description': 'Microbiological cure: no isolation of the causative agent in the infective site at 72 hours and end of treatment Microbiological failure: persistence of the causative agent in the infective site at 72 hours'}, {'measure': 'Number of participants with microbiological cure after completion of therapy', 'timeFrame': 'Baseline, day 3', 'description': 'Microbiological cure: no isolation of the causative agent in the infective site at 72 hours and end of treatment Microbiological failure: persistence of the causative agent in the infective site at 72 hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['carbapenem resistant Acinetobacter baumanni', 'CRAB', 'Colistin', 'Fosfomycin'], 'conditions': ['Infection Due to Carbapenem Resistant Acinetobacter']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the efficacy of colistin compared with colistin plus fosfomycin against carbapenem-resistant Acinetobacter baumanii infection in Thailand. The main questions it aims to answer the following main questions:\n\n1. Which group has better clinical response at end of treatment\n2. Which group has better clinical response at 72 hours and micrological cure at 72 hours and at end of treatment', 'detailedDescription': 'Participants will be randomized in a 1:1 ratio to receive a combination of intravenous colistin plus intravenous fosfomycin (combination group) or colistin alone (monotherapy group) to determine if monotherapy or combination therapy has a better outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 20 years old patients who have CRAB infections (pneumonia, urinary tract infection, skin and soft tissue infection, bloodstream infection)\n* Able to provide informed consent or having a legal proxy who can provide informed consent in case the subject is unable to provide consent on his own\n\nExclusion Criteria:\n\n* Minimum inhibitory concentration (MIC) of colistin \\> 2 mg/L\n* Complicated infection with inadequate source controlled\n* Intracranial infection\n* Infective endocarditis\n* Intraabdominal infection\n* Bone and joint infection\n* Allergic to or have contraindication(s) to any treatment regimen in the study\n* Polymicrobial infection with Carbapenem-resistant Psuedomonas aeruginosa, Carbapenem-resistant Enterobacterales (CRE), Vancomycin-resistant Enterococcus (VRE)\n* Pregnancy\n* Previous treatment with colistin or fosfomycin more than 96 hours\n* Life expectancy of 24 hour or less\n* Refusal to participate in the study\n* Hospice treatment'}, 'identificationModule': {'nctId': 'NCT06570850', 'briefTitle': 'Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Efficacy of Colistin Monotherapy Versus Colistin Combined With Fosfomycin Against Carbapenem-Resistant Acinetobacter Baumannii Infections', 'orgStudyIdInfo': {'id': 'MED-2566-09378'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Colistin group', 'description': 'Participants receive intravenous colistin (colistinmethate soidum) 5 mg/kg/day (dosage will be adjusted according to creatinine clearance) and colistin nebulization at 80 mg every 8 hours in case of pneumonia.', 'interventionNames': ['Drug: Colistin Sodium Methanesulfonate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Colistin plus fosfomycin group', 'description': 'Participants receive intravenous colistin (colistinmethate soidum) (dosage regimen same as colistin group plus intravenous fosfomycin (dosage will be adjusted according to creatinine clearance and MIC).', 'interventionNames': ['Drug: Colistin Sodium Methanesulfonate plus Fosfomycin']}], 'interventions': [{'name': 'Colistin Sodium Methanesulfonate', 'type': 'DRUG', 'otherNames': ['Colistin'], 'description': 'Intravenous colistin (colistinmethate soidum) 5 mg/kg/day intravenous (dosage will be adjusted according to creatinine clearance). The duration of treatment ranges from 10 to 14 days, depending on the site of infection and clinical responsiveness.', 'armGroupLabels': ['Colistin group']}, {'name': 'Colistin Sodium Methanesulfonate plus Fosfomycin', 'type': 'DRUG', 'otherNames': ['Colistin plus fosfomycin'], 'description': 'Intravenous colistin(dosage is same as colistin group) plus intravenous fosfomycin(dosage will be adjusted according to MIC and creatinine clearance). The duration of treatment ranges from 10 to 14 days, depending on the site of infection and clinical responsiveness.', 'armGroupLabels': ['Colistin plus fosfomycin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Athitaya Luangnara', 'role': 'CONTACT', 'email': 'fenejung2@gmail.com', 'phone': '0954970567'}, {'name': 'Parichat Salee', 'role': 'CONTACT', 'email': 'parichat.pimsarn@gmail.com', 'phone': '0817830755'}], 'facility': 'Faculty of medicine, Chiang Mai university', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'centralContacts': [{'name': 'Athitaya Luangnara', 'role': 'CONTACT', 'email': 'fenejung2@gmail.com', 'phone': '0954970567'}, {'name': 'Parichat Salee', 'role': 'CONTACT', 'email': 'parichat.pimsarn@gmail.com', 'phone': '0817830755'}], 'overallOfficials': [{'name': 'Athitaya Luangnara', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chiang Mai University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor Parichat sales', 'investigatorFullName': 'Parichat Salee', 'investigatorAffiliation': 'Chiang Mai University'}}}}