Clinical trial

Therapeutic Strategies for Carbapenem-Resistant Acinetobacter Baumannii Infections: Study Protoco

Name
CRAB01
Description
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. 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 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.
Trial arms
Trial start
2024-11-01
Estimated PCD
2026-12-01
Trial end
2027-02-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Fosfomycin
Patients will be randomly divided according to a predetermined randomization table Upon arrival of a positive microbiological finding on A. baumannii, patient will be randomised to one of groups (Colistin with Unasyn OR Colistin with Xerava OR Colistin with Fosfomycin
Arms:
Fosfo
Other names:
Fosfomycin with Colistin
Eravacycline
Patients will be randomly divided according to a predetermined randomization table Upon arrival of a positive microbiological finding on A. baumannii, patient will be randomised to one of groups (Colistin with Unasyn OR Colistin with Xerava OR Colistin with Fosfomycin
Arms:
Xerava
Other names:
Eravacycline with Colistin
Unasyn
Patients will be randomly divided according to a predetermined randomization table Upon arrival of a positive microbiological finding on A. baumannii, patient will be randomised to one of groups (Colistin with Unasyn OR Colistin with Xerava OR Colistin with Fosfomycin
Arms:
Unasin
Other names:
Unasyn with Colistin
Size
108
Primary endpoint
Negativisation
10 days
Eligibility criteria
Inclusion Criteria: * Surgical patients (abdominal, vascular, and polytraumatized patients) * older than 18 years * who require postoperative treatment in the ICU * A positive sample (surveillance or diagnostic) for A. baumannii with signs of systemic infection. * Infection is defined as a diagnostic microbiologically positive sample for A. baumannii and a surveillance microbiologically positive sample for A. baumannii with signs of systemic infection (CRP, L, and body temperature) * Colonisation is a positive surveillance microbiological sample for A. baumannii in the absence of signs of systemic infection (CRP, L, and body temperature). Exclusion Criteria: * Allergy to medicines * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 108, 'type': 'ESTIMATED'}}
Updated at
2024-06-03

1 organization

3 products

3 indications

Product
Fosfomycin
Indication
Infections
Indication
Bacteria
Indication
Sepsis
Product
Unasyn