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NCT Number: NCT07369336

Clinical Outcomes of Inhaled Amikacin in Ventilator Associated Pneumonia

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.

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Key information

Conditions

Ventilator Associated Pneumonia ( VAP) Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lahore General Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion Criteria

Participants must meet all of the following:

  • Age 18-80 years
  • Currently receiving invasive mechanical ventilation
  • 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

  • Initiation of systemic IV antibiotics for VAP
  • Availability of baseline respiratory sample for culture
  • Informed consent obtained from patient's legal guardian/attendantExclusion Criteria

Any of the following will lead to exclusion:

  • Known hypersensitivity to aminoglycosides (e.g., amikacin)
  • Chronic kidney disease Stage 4-5 or baseline serum creatinine >2 mg/dL
  • Pre-existing hearing loss or vestibular dysfunction
  • Severe bronchospasm or airway instability preventing safe nebulization
  • VAP due to confirmed pan-resistant microorganisms requiring alternative therapy

Exclusion criteria

-

Treatment and study plan

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 Antibiotics

Drug

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

Primary outcomes

  1. Duration of invasive mechanical ventilation

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

    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.

Secondary outcomes

  1. Clinical Improvement on Day 7

    Time frame: Day 7 after initiation of study treatment

    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.

Sponsors and collaborators

Lead sponsor

Postgraduate Medical Institute, Lahore

Other

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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