| NCT ID | NCT06440304 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Clinical Hospital Centre Zagreb |
| Condition | Infections, Bacterial |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2025-01-30 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 108 participants in total. It began in 2025-01-30 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
CRAB infections in ICUs are on the rise, leading to higher morbidity, mortality, and healthcare costs due to resistance to most antibiotics, including carbapenems. The main resistance mechanisms include carbapenemases, efflux pumps, and changes in the bacterial cell wall. Current treatments include polymyxins (Colistin, Polymyxin B), which are effective but can lead to resistance, aminoglycosides (Amikacin, Gentamicin), which are limited by resistance, and tetracyclines (Tigecycline, Eravacycline), which are effective against CRAB. Fosfomycin is effective in combination treatments, and combination therapy (e.g., colistin with sulbactam, fosfomycin, or eravacycline) can enhance outcomes. Previous research shows promise for combination therapies, improving treatment efficacy and reducing mortality. New regimens are being studied to find optimal combinations. Individualized dosing is crucial, considering patient-specific factors like age, weight, and renal function. Adjustments depend on the infection site and comorbidities. Strict infection control and antimicrobial stewardship programs (ASPs) are essential. ASPs focus on optimizing antibiotic use and reducing resistance through education and surveillance. Future directions include continued research for new drugs or combinations and strategies to overcome resistance and improve treatment efficacy. Study goals include achieving negative samples after 10 days of therapy, 30-day survival, discharge rates, reduced SOFA scores, and improved clinical and radiological findings. A randomized study will compare colistin combined with fosfomycin, ampicillin/sulbactam, and eravacycline. In summary, treating CRAB infections is complex, requiring combination therapy, individualized dosing, and strict infection control measures.
Eligibility 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
Contact & Investigator
Ivan Šitum
PRINCIPAL INVESTIGATOR
UHC Zagreb
Frequently Asked Questions
Who can join the NCT06440304 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Infections, Bacterial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06440304 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06440304 currently recruiting?
Yes, NCT06440304 is actively recruiting participants. Contact the research team at ivsitum@gmail.com for enrollment information.
Where is the NCT06440304 trial being conducted?
This trial is being conducted at Zagreb, Croatia.
Who is sponsoring the NCT06440304 clinical trial?
NCT06440304 is sponsored by Clinical Hospital Centre Zagreb. The principal investigator is Ivan Šitum at UHC Zagreb. The trial plans to enroll 108 participants.