NCT06570850

Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection

Efficacy of Colistin Monotherapy Versus Colistin Combined With Fosfomycin Against Carbapenem-Resistant Acinetobacter Baumannii Infections

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Chiang Mai University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

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 monotherapy or combination therapy has a better outcome.

Conditions

• Infection Due to Carbapenem Resistant Acinetobacter

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-03-01
• Completion: 2025-07-01
• First posted: 2024-08-26
• Last updated: 2024-08-26

Locations

1 site across 1 country: Thailand