drugset / Trial / NCT06808074

A Study to Evaluate Role of Inhaled Amikacin to Prevent Ventilator Associated Pneumonia in Patients With Cirrhosis

NCT06808074

Phase 4 Recruiting 162 enrolled Asian Institute of Gastroenterology, India
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The recent AMIKINHAL trial found that prophylactic inhaled amikacin was effective in lowering the incidence of ventilator-associated pneumonia in ICU patients. Since aspiration is a common complication of cirrhosis patients with HE (7 out of 10 patients develop some type of HE) who are hospitalized to the liver ICU also have an elevated risk of Ventilator associated pneumonia. Despite supportive care and appropriate antimicrobial therapy pneumonia is linked to greater mortality in cirrhosis. This poses a significant challenge to physicians. Due to the lack of randomized controlled trials (RCTs) on the prophylaxis of VAP in cirrhosis patients with HE, conducting this study is necessary to evaluate the efficacy of inhaled amikacin. The study results may provide evidence -based guidance for therapy in this patient population.

Timeline

Start
2025-02-12
Primary completion
2026-02
Completion
2026-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Amikacin Small molecule 20 mg/kg Inhaled