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

Condition(s) studied

Investigational drug(s) / intervention(s)

Meropenem Injection: Meropenem 2 gm iv TDS

Ceftazidime-avibactam: Ceftazidime-avibactam 2.5 gm iv TDS

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

Study 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

Primary outcome measure(s)

• Proportion of ACLF patients with nosocomial infection by carbapenem resistant organisms showing clinical response at the end of treatment. — Day 3

Trial sites (1)

More Institute of Liver and Biliary Sciences, India trials in India

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