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

Inhaled Amikacin as a Prophylaxis for Ventilator Associated Pneumonia in Patients With Cirrhosis: A Randomized Placebo Controlled Double Blind Study

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatic Encephalopathy; Cirrhosis; Ventilator Associated Pneumonia (VAP)
• Intervention / Treatment: Drug: Inhaled amikacin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anand V Kulkarni; Phone Number: + 8553322434; Email: anandvk90@gmail.com

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500032
      • Recruiting
      • AIG Hospitals
      • Contact: Kulkarni; Phone Number: +918553322434; Email: anandvk90@gmail.com
    • Hyderabad, Telangana, India, 500032
      • Recruiting
      • Asian Institute Of Gastroenterology
      • Contact: Anand V Kulkarni; Phone Number: + 8553322434; Email: anandvk90@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients admitted to the liver ICU with hepatic encephalopathy (Grade 2 or higher), requiring intubation for at least 48 hours, without pneumonia.
2. Patient is aged ≥18 years.
3. Written informed consent of the patient or a proxy.

Exclusion Criteria:

1. Suspected or confirmed Pneumonia at the day of inclusion.
2. Patients with Chronic kidney disease on maintenance hemodialysis
3. Stage 2 or 3 Kidney Disease Improving Global Outcome (KDIGO) classification AKI the day of inclusion. Patients undergoing renal replacement therapy or for whom decision has been made to initiate renal replacement therapy can be included whatever the KDIGO stage
4. Pregnancy or breast-feeding.
5. Clinical indication for systemic aminoglycoside therapy the day of inclusion: as deemed necessary by the clinician in charge.
6. Patients known to be allergic to aminoglycosides.
7. Patients who received intravenous Amikacin before 7 days of inclusion in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; The equivalent volume of saline solution (0.9% sodium chloride [NaCl]) will be administered once daily for three consecutive days
Experimental: Inhaled Amikacin	Drug: Inhaled amikacin; Dosage of amikacin: 20 mg/kg based on ideal body weight, with a maximal dose of 2 g, once daily for 3 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Ventilator associated pneumonia	At day 7 and day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause in-hospital mortality	Day 28
Incidence of infections at other sites (Intrabdominal, Blood stream, Urinary tract, Skin and soft tissue)	Day 7, 14, 28
Time to resolution of Hepatic encephalopathy	Day 7, 14, 28
No. of ventilator free ICU days	Day 28
Incidence of Acute kidney injury	Day 7, 14, 28

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Prophylaxis; Ventilator associated pneumonia; Inhaled amikacin
• Additional Relevant MeSH Terms: Healthcare-Associated Pneumonia; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Disease Attributes; Metabolic Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Liver Diseases; Brain Diseases, Metabolic; Liver Failure; Hepatic Insufficiency; Cross Infection; Iatrogenic Disease; Pneumonia; Fibrosis; Liver Cirrhosis; Brain Diseases; Pneumonia, Ventilator-Associated; Hepatic Encephalopathy; Anti-Bacterial Agents; Anti-Infective Agents; Amikacin
• Other Study ID Numbers: AIG/IEC-BH&R 62/09.2024-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No