Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection

August 22, 2024 updated by: Parichat Salee, Chiang Mai University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

188

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Colistin group
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.
Drug: Colistin 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.
Other Names:
  • Colistin
Active Comparator: Colistin plus fosfomycin group
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).
Drug: Colistin 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.
Other Names:
  • Colistin plus fosfomycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, day 10-14 (end of therapy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, day 3
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
Baseline, day 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
Baseline, day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Investigators

  • Principal Investigator: Athitaya Luangnara, Chiang Mai University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-2566-09378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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