Comparing colistin alone to colistin with fosfomycin for treating CRAB infections
Efficacy of Colistin Monotherapy Versus Colistin Combined With Fosfomycin Against Carbapenem-Resistant Acinetobacter Baumannii Infections
This study is testing whether using colistin alone or combining it with fosfomycin is better for treating tough infections caused by carbapenem-resistant Acinetobacter baumannii in Thailand.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Chiang Mai University Academic / other |
| Locations | 1 site (Chiang Mai) |
| Trial ID | NCT06570850 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of colistin monotherapy versus a combination of colistin and fosfomycin in treating infections caused by carbapenem-resistant Acinetobacter baumannii in Thailand. Participants will be randomly assigned to receive either colistin alone or the combination therapy to determine which approach yields better clinical outcomes. The study aims to assess clinical responses at the end of treatment and at 72 hours, as well as microbiological cure rates at these time points.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 and older diagnosed with CRAB infections such as pneumonia, urinary tract infections, or bloodstream infections.
Not a fit: Patients with a minimum inhibitory concentration of colistin greater than 2 mg/L or those with complicated infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from CRAB infections.
How similar studies have performed: Other studies have explored combination therapies for resistant infections, but this specific comparison of colistin and fosfomycin is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chiang Mai
- Faculty of medicine, Chiang Mai university — Chiang Mai, Thailand (Recruiting)
Study contacts
- Principal investigator: Athitaya Luangnara — Chiang Mai University
- Study coordinator: Athitaya Luangnara
- Email: fenejung2@gmail.com
- Phone: 0954970567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.