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

NCT06818565 | Not Yet Recruiting

• 1 other identifier: ILBS-ACLF-20
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute-On-Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

• Proportion of ACLF patients with nosocomial infection by carbapenem resistant organisms showing clinical response at the end of treatment.

  Day 3

Secondary Outcomes (5)

• Time to escalation or descalation of antibiotics

  within 3 days

• Progression in terms of organ dysfunction/failure at day 5 and 7.

  day 5 and 7

• Incidence of adverse events in both groups.

  within 7 to 10 days

• Duration of hospital and ICU stay

  day 28

• Mortality at day 15 and day 28

  day 15 & 28

Study Arms (2)

Meropenem

ACTIVE COMPARATOR

Meropenem 2gm TDS over 3 hours infusion Teicoplanin 400 mg iv BD for 3 doses f/b 400 mg iv OD

Drug: Meropenem Injection; Drug: Teicoplanin

Ceftazidime avibactam

EXPERIMENTAL

Ceftazidime avibactam 2.5 gm iv TDS. Teicoplanin 400 mg iv BD for 3 doses f/b 400 mg iv OD

Drug: Ceftazidime-avibactam; Drug: Teicoplanin

Interventions

Meropenem Injection DRUG

Meropenem 2 gm iv TDS

Meropenem

Ceftazidime-avibactam DRUG

Ceftazidime-avibactam 2.5 gm iv TDS

Ceftazidime avibactam

Teicoplanin DRUG

Teicoplanin 400 mg iv BD 3 doses followed by 400mg iv OD

Ceftazidime avibactam; Meropenem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• ACLF as per APASL criteria
• 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.

You may not qualify if:

• Severe septic shock with MOF requiring escalation of antibiotics
• Patients having known allergies to meropenem or Ceftazidime Avibactam
• Culture sensitivity showing isolate non susceptible to study drug being investigated.
• Already on either regimen, receiving meropenem or Ceftazidime Avibactam \>48 hours.
• On mechanical ventilator support PF ratio \< 300.
• Patients on immunosuppression medication
• HCC or other malignancies
• CKD
• CAD
• Pregnancy or Lactation
• Post Liver Transplantation
• Refusal to consent
• PLWHA

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Interventions

Meropenem; avibactam, ceftazidime drug combination; Teicoplanin

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lipoglycopeptides; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Dr Amanjot Kaur, MD

CONTACT

01146300000; amanjotbahri@gmail.com

Prof. Rakhi Maiwall, DM

CONTACT

01146300000; rakhi_2011@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 10, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-01

Locations

IN (1)