Ceftazidime-avibactam vs high-dose meropenem for ACLF patients with hospital-acquired infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional trial compares two antibiotic strategies for ACLF patients who develop hospital-acquired infections due to carbapenem-resistant organisms. Participants receive either ceftazidime-avibactam or extended-infusion high-dose meropenem as empirical therapy, with primary focus on clinical response by day 3. Secondary goals include microbiologic outcomes, antibiotic escalation/de-escalation decisions, ICU transfer, mortality, organ failure progression, and transplant eligibility. The study also explores pathogen spectra, resistance genes, host biomarkers, and transplant-free survival through day 28. Eligible adults with ACLF per APASL criteria and confirmed nosocomial infection are enrolled at ILBS, New Delhi.

Why it matters

Who can join: the full rules

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

Where it's running

• Institute of Liver & Biliary Sciences (ILBS)
  New Delhi, National Capital Territory of Delhi, India Recruiting

Study contacts

• Study coordinator: Dr Amanjot Kaur, MD
• Email: amanjotbahri@gmail.com
• Phone: 01146300000

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.