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NCT Number: NCT06570850

Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection

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

Recruiting

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Key information

Conditions

Infection Due to Carbapenem Resistant Acinetobacter

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colistin Sodium Methanesulfonate

Drug

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.

Other names: Colistin

Colistin Sodium Methanesulfonate plus Fosfomycin

Drug

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.

Other names: Colistin plus fosfomycin

Primary outcomes

  1. Number of participants with clinical response after completion of therapy

    Time frame: 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 outcomes

  1. Number of participants with clinical response at 72 hours of therapy

    Time frame: 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.

  2. Number of participants with microbiological cure at 72 hours of therapy

    Time frame: 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

  3. Number of participants with microbiological cure after completion of therapy

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Athitaya Luangnara

CONTACT

[email protected]

0954970567

Parichat Salee

CONTACT

[email protected]

0817830755

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.