Status:
RECRUITING
Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection
Lead Sponsor:
Chiang Mai University
Conditions:
Infection Due to Carbapenem Resistant Acinetobacter
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
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 quest...
Detailed Description
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 mo...
Eligibility Criteria
Inclusion
- ≥ 20 years old patients who have CRAB infections (pneumonia, urinary tract infection, skin and soft tissue infection, bloodstream infection)
- 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
Exclusion
- Minimum inhibitory concentration (MIC) of colistin \> 2 mg/L
- Complicated infection with inadequate source controlled
- Intracranial infection
- Infective endocarditis
- Intraabdominal infection
- Bone and joint infection
- Allergic to or have contraindication(s) to any treatment regimen in the study
- Polymicrobial infection with Carbapenem-resistant Psuedomonas aeruginosa, Carbapenem-resistant Enterobacterales (CRE), Vancomycin-resistant Enterococcus (VRE)
- Pregnancy
- Previous treatment with colistin or fosfomycin more than 96 hours
- Life expectancy of 24 hour or less
- Refusal to participate in the study
- Hospice treatment
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT06570850
Start Date
April 1 2023
End Date
July 1 2025
Last Update
August 26 2024
Active Locations (1)
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1
Faculty of medicine, Chiang Mai university
Chiang Mai, Thailand, 50200