About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Fosfomycin
DrugPatients 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
Eravacycline
DrugPatients 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
ampicillin/sulbactam
DrugPatients 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
Treatment groups
Trial outcomes
Primary outcomes
Negativisation
Rate of negativisation of (surveillance or diagnostic) microbiological sample;
Secondary outcomes
Length of stay in ICU
Days spent in ICU total after randomisation
Length of stay in hospital
Days spent in hospital total after randomisation
Reduction of Sequential Organ Failure Assessment (SOFA) score
Change in initial SOFA score from randomisation day, from 0 points to 24
Other outcomes
30 day Survival
patients survived 30 days after randomisation
Reduction of inflamatory parameters
Reduction of parameters of inflamation (L,CRP, PCT)
Sponsors and contacts
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