New treatment options for infections caused by drug-resistant bacteria
Therapeutic Strategies for Carbapenem-Resistant Acinetobacter Baumannii Infections: Study Protocol
This study is testing different combinations of antibiotics to see if they can help ICU patients with tough infections caused by drug-resistant bacteria.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Clinical Hospital Centre Zagreb Academic / other |
| Locations | 1 site (Zagreb) |
| Trial ID | NCT06440304 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of various combination therapies for treating infections caused by carbapenem-resistant Acinetobacter baumannii (CRAB) in ICU patients. Participants will receive one of three treatment regimens involving colistin combined with either fosfomycin, ampicillin/sulbactam, or eravacycline. The primary goal is to achieve negative culture results after 10 days of therapy, while secondary objectives include assessing survival rates, ICU discharge, and reduction in infection severity. The study will also monitor patient-specific factors to tailor individual treatment plans.
Who should consider this trial
Good fit: Ideal candidates include surgical patients over 18 years old who require ICU treatment and have a positive sample for A. baumannii with signs of systemic infection.
Not a fit: Patients with allergies to the study medications or those with positive findings for carbapenem-sensitive A. baumannii may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and reduced mortality for patients with severe CRAB infections.
How similar studies have performed: Previous studies have shown promise for combination therapies in treating CRAB infections, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Surgical patients (abdominal, vascular, and polytraumatized patients) * Older than 18 years * Require postoperative treatment in the ICU * A positive sample (surveillance or diagnostic) for A. baumannii with signs of systemic infection Infection will be defined as a diagnostic microbiologically positive sample for A. baumannii and a surveillance microbiologically positive sample for A. baumannii with signs of systemic infection (elevated CRP, leukocytes, and body temperature). Colonization will be defined as a positive surveillance microbiological sample for A. baumannii in the absence of signs of systemic infection (normal CRP, leukocytes, and body temperature). Exclusion Criteria: * Allergy to the study medications * Positive surveillance swabs for A. baumannii without signs of systemic infection * Positive findings (surveillance or diagnostic) for carbapenem-sensitive A. baumannii * Refusal to participate in the research
Where this trial is running
Zagreb
- University Hospital Centre Zagreb — Zagreb, Croatia (Recruiting)
Study contacts
- Principal investigator: Ivan Šitum — UHC Zagreb
- Study coordinator: Ivan Šitum
- Email: ivsitum@gmail.com
- Phone: 0915143620
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.