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Recruiting NCT06818565

Comparison of Efficacy and Safety of Ceftazidime Avibactam Versus Extended Infusions of High Dose Meropenem in Patients of ACLF With Nosocomial Infections.

Conditions: Acute-On-Chronic Liver Failure

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Institute of Liver and Biliary Sciences, India

Location: Institute of Liver & Biliary Sciences (ILBS) New Delhi National Capital Territory of Delhi

Summary

Acute on chronic liver failure patients are at high risk for nosocomial infections due to liver dysfunction, which impairs immune responses and increases vulnerability to infections. Key factors contributing to nosocomial infections in ACLF patients include ascites, use of invasive devices, and recent hospitalization, frequent need for broad spectrum antibiotics. Multidrug resistance is a growing issue, making treatment more challenging, common pathogens involved are gram negative bacteria such as Escherichia Coli and Klebsiella pneumoniae. Surveillance data show increasing carbapenem resistant enterobacterales (CRE) infection rates in cirrhotics, with high morbidity and mortality rates. The impact of these nosocomial infections is profound, significantly worsen outcomes in ACLF patients, leading to prolonged hospitalizations, increased health care costs and higher mortality rates. Early detection and effective antibiotic stewardship are essential to manage antibiotic resistance and improve patient outcomes. In this study we aim to compare efficacy and safety of Ceftazidime avibactam versus extended infusions of high dose Meropenem in patients of ACLF with nosocomial infections.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18 years 2. ACLF as per APASL criteria 3. ACLF patients with nosocomial infections caused by carbapenem resistant organism (defined as suspected or documented evidence of infection after 48 hours of hospitalization) requiring antibiotics. Exclusion Criteria: 1. Severe septic shock with MOF requiring escalation of antibiotics 2. Patients having known allergies to meropenem or Ceftazidime Avibactam 3. Culture sensitivity showing isolate non susceptible to study drug being investigated. 4. Already on either regimen, receiving meropenem or Ceftazidime Avibactam \>48 hours. 5. On mechanical ventilator support PF ratio \< 300. 6. Patients on immunosuppression medication 7. HCC or other malignancies 8. CKD 9. CAD 10. Pregnancy or Lactation 11. Post Liver Transplantation 12. Refusal to consent 13. PLWHA

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06818565). StuddyBuddy aggregates publicly available trial information.