Clinical Outcomes of Inhaled Amikacin in Ventilator Associated Pneumonia

Postgraduate Medical Institute, Lahore90 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Interventions

Amikacin (Inhalation)DRUG

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.

Standard-of-Care Intravenous AntibioticsDRUG

Intravenous antibiotics selected based on local antimicrobial guidelines and pathogen sensitivity for ventilator-associated pneumonia, administered for the full

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Inclusion Criteria Participants must meet all of the following: 1. Age 18-80 years 2. Currently receiving invasive mechanical ventilation 3. Clinical diagnosis of ventilator-associated pneumonia (VAP) based on: New or progressive infiltrate on chest imaging and at least two of the following: Fever \> 38°C or hypothermia \< 36°C Leukocytosis \>12,000 or leukopenia \<4,000 cells/µL Increased purulent respiratory secretions Worsening oxygenation indices 4. Initiation of systemic IV antibiotics for VAP 5. Availability of baseline respiratory sample for culture 6. Informed consent obtained from patient's legal guardian/attendantExclusion Criteria Any of the following will lead to exclusion: 1. Known hypersensitivity to aminoglycosides (e.g., amikacin) 2. Chronic kidney disease Stage 4-5 or baseline serum creatinine \>2 mg/dL 3. Pre-existing hearing loss or vestibular dysfunction 4. Severe bronchospasm or airway instability preventing safe nebulization 5. VAP due to confirmed pan-resistant microorganisms requiring alternative therapy Exclusion Criteria: \-

Outcomes

Primary Outcomes

Duration of invasive mechanical ventilation

The total number of consecutive days a participant remains on invasive mechanical ventilation following enrollment. Extubation is considered successful if the participant remains off the ventilator for at least 48 hours without the need for reintubation.

Time frame: From randomization until successful discontinuation of mechanical ventilation, assessed up to 28 days

Secondary Outcomes

Clinical Improvement on Day 7

The proportion of participants achieving a predefined composite improvement in clinical status, including: Reduction in sputum volume and purulence Reduction in requirement for oxygen support Improvement in PaO₂/FiO₂ ratio Radiological improvement on chest imaging Resolution of fever (temperature \<38°C for \>24 hours) Measured using standardized clinical criteria for ventilator-associated pneumonia.

Time frame: Day 7 after initiation of study treatment