RecruitingPhase 4NCT06440304

Therapeutic Options for CRAB

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


Sponsor

Clinical Hospital Centre Zagreb

Enrollment

108 participants

Start Date

Jan 30, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria6

  • 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 Criteria4

  • 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

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Interventions

DRUGFosfomycin

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

DRUGEravacycline

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

DRUGampicillin/sulbactam

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


Locations(1)

University Hospital Centre Zagreb

Zagreb, Croatia

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NCT06440304


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