Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection

Last updated: August 22, 2024
Sponsor: Chiang Mai University
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Colistin Sodium Methanesulfonate plus Fosfomycin

Colistin Sodium Methanesulfonate

Clinical Study ID

NCT06570850
MED-2566-09378
  • Ages > 20
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • ≥ 20 years old patients who have CRAB infections (pneumonia, urinary tractinfection, skin and soft tissue infection, bloodstream infection)

  • Able to provide informed consent or having a legal proxy who can provide informedconsent in case the subject is unable to provide consent on his own

Exclusion

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

Study Design

Total Participants: 188
Treatment Group(s): 2
Primary Treatment: Colistin Sodium Methanesulfonate plus Fosfomycin
Phase: 4
Study Start date:
April 01, 2023
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Faculty of medicine, Chiang Mai university

    Chiang Mai, 50200
    Thailand

    Active - Recruiting

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