Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection
NCT06570850 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 188
Last updated 2024-08-26
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 questions it aims to answer the following main questions:
1. Which group has better clinical response at end of treatment
2. Which group has better clinical response at 72 hours and micrological cure at 72 hours and at end of treatment
Conditions
- Infection Due to Carbapenem Resistant Acinetobacter
Interventions
- DRUG
-
Colistin Sodium Methanesulfonate
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.
- DRUG
-
Colistin Sodium Methanesulfonate plus Fosfomycin
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.
Sponsors & Collaborators
-
Chiang Mai University
lead OTHER
Principal Investigators
-
Athitaya Luangnara · Chiang Mai University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-01
- Primary Completion
- 2025-03-31
- Completion
- 2025-07-31
Countries
- Thailand
Study Locations
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