NCT06818565

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Hypothesis - We hypothesize that ceftazidime-avibactum would be superior and an effective carbapenem sparing agent compared to extended high dose carbapenems as empirical therapy in management of nosocomial infections caused by carbapenem resistant organisms in patients with ACLF. Aim -To compare the efficacy and safety of Ceftazidime avibactam and extended infusions of high dose Meropenem as emperical antibiotic in patients of ACLF with nosocomial infections caused by carbapenem resistant organisms. Primary objective: • To compare the efficacy of Ceftazidime avibactam over extended infusions of high dose carabapenem as emperical antibiotic in achieving clinical response at day 3 in patients of ACLF with suspected nosocomial infections. Secondary objectives: * To study the spectrum of nosocomial infections, bacterial DNA and resistance genes in the context of nosocomial infections in ACLF * Proportion of patients requiring escalation/de-escalation of antibiotics at day 3 * Incidence of clinical and microbiologic response at day 5 and day 7 * Time to escalation of antibiotics in both groups * Transfer to icu, mortality, and progression of organ failures and worsening of AARC scores by grade I, SOFA score by point 2. * Microbiologic outcome (Eradication/Persistence) * To identify biomarkers of host response to empirical antibiotic regimen * Transplant free survival at day 15 and day 28 * Proportion of patients made eligible for transplant day 7. A prospective, Randomized Control Trial. Single centre, Open label, Block randomization will be done, it will be implemented by IWRS method. This study will be conducted in Department of Hepatology, ILBS.

Conditions

• Acute-On-Chronic Liver Failure

Interventions

Type	Name	Description
DRUG	Meropenem Injection	Meropenem 2 gm iv TDS
DRUG	Ceftazidime-avibactam	Ceftazidime-avibactam 2.5 gm iv TDS
DRUG	Teicoplanin	Teicoplanin 400 mg iv BD 3 doses followed by 400mg iv OD

Timeline

• Start date: 2025-02-10
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-02-10
• Last updated: 2025-02-10

Locations

1 site across 1 country: India