Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection

Chiang Mai University

Status and phase: Enrolling; Phase 4

Conditions: Infection Due to Carbapenem Resistant Acinetobacter

Treatments: Drug: Colistin Sodium Methanesulfonate plus Fosfomycin; Drug: Colistin Sodium Methanesulfonate

Study type: Interventional

Funder types: Other

Identifiers

NCT06570850

MED-2566-09378

Details and patient eligibility

About

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

Full 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.

Enrollment: 188 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

Colistin group

Active Comparator 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.

Treatment:

Drug: Colistin Sodium Methanesulfonate

Colistin plus fosfomycin group

Active Comparator 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).

Treatment:

Drug: Colistin Sodium Methanesulfonate plus Fosfomycin