RecruitingPhase 4NCT06570850

Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection

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


Sponsor

Chiang Mai University

Enrollment

188 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 20 Years

Inclusion Criteria2

  • ≥ 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 Criteria13

  • 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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Interventions

DRUGColistin 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.

DRUGColistin 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.


Locations(1)

Faculty of medicine, Chiang Mai university

Chiang Mai, Thailand

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NCT06570850