NCT07369336

Clinical Outcomes of Inhaled Amikacin in Ventilator Associated Pneumonia

Clinical Outcomes of Inhaled Amikacin in Ventilator Associated Pneumonia:A Group Randomized Controlled, Add on Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Postgraduate Medical Institute, Lahore · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Article: Clinical Outcomes of Inhaled Amikacin in Ventilator-Associated Pneumonia: A group randomized controlled,add-on trial English:Patients in intensive care units often need ventilators to breathe. Sadly, these machines sometimes cause serious lung infections, known as ventilator-associated pneumonia (VAP). This study tested whether giving the antibiotic amikacin by inhalation (so itgoes straight into the lungs) could improve recovery when added to regular treatment. Researchers looked at how quickly infections cleared, how long patients needed the ventilator, and whether hospital stays were shortened. They also monitored for side effects.

Detailed description

Ventilator-associated pneumonia continues to pose a significant therapeutic challenge due to rising antimicrobial resistance and suboptimal lung penetration of systemic antibiotics. Inhaled amikacin offers the advantage of delivering high local drug concentrations in the respiratory tract with minimal systemic toxicity. This group randomized controlled add-on trial was conducted in the Surgical Intensive Care Units of Lahore General Hospital, Pakistan, from January to December 2024. A total of 180 adult patients diagnosed with VAP were allocated to one of two treatment arms: Group N (Control): Empirical intravenous antibiotics (Meropenem ± Moxifloxacin) Group A (Intervention): Inhaled amikacin (20 mg/kg/day in two divided doses) in addition to empirical intravenous antibiotics Randomization was computer-generated and stratified by age, gender, and baseline SOFA score. Clinical outcomes assessed included fever resolution, leukocyte normalization, reduced oxygen requirement, radiographic improvement, ventilator weaning, duration of mechanical ventilation, and length of ICU stay. Composite clinical improvement was defined as improvement in at least three out of five predefined domains.

Conditions

• Ventilator Associated Pneumonia ( VAP)

Interventions

Type	Name	Description
DRUG	Amikacin (Inhalation)	Amikacin administered as an aerosolized solution via a vibrating mesh nebulizer once daily for the duration of systemic antibiotic therapy, according to ICU protocol for ventilator-associated pneumonia.
DRUG	Standard-of-Care Intravenous Antibiotics	Intravenous antibiotics selected based on local antimicrobial guidelines and pathogen sensitivity for ventilator-associated pneumonia, administered for the full

Timeline

• Start date: 2024-01-05
• Primary completion: 2024-11-25
• Completion: 2025-09-30
• First posted: 2026-01-27
• Last updated: 2026-01-27

Locations

1 site across 1 country: Pakistan