Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection

Phase 4

Recruiting

• Conditions: Infection Due to Carbapenem Resistant Acinetobacter
• Interventions: Drug: Colistin Sodium Methanesulfonate; Drug: Colistin Sodium Methanesulfonate plus Fosfomycin

• Registration Number: NCT06570850
• Lead Sponsor: Chiang Mai University

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 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.

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Primary Completion: 2025-03
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

• ≥ 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colistin group	Colistin Sodium Methanesulfonate	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.
Colistin plus fosfomycin group	Colistin Sodium Methanesulfonate plus Fosfomycin	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).

Primary Outcome Measures

Name	Time	Method
Number of participants with clinical response after completion of therapy	Baseline, day 10-14 (end of therapy)	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants with clinical response at 72 hours of therapy	Baseline, day 3	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.
Number of participants with microbiological cure at 72 hours of therapy	Baseline, day 3	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
Number of participants with microbiological cure after completion of therapy	Baseline, day 3	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

Trial Locations

Locations (1)

Faculty of medicine, Chiang Mai university; 🇹🇭 Chiang Mai, Thailand