A Phase 4 interventional study of Amikacin (Inhalation) and Standard-of-Care Intravenous Antibiotics in Ventilator Associated Pneumonia ( VAP), sponsored by Postgraduate Medical Institute, Lahore. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Postgraduate Medical Institute, Lahore · Phase 4, Interventional, and Treatment
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.
420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 85 are open to participants now.
This study's enrollment of 90 is below the median of 115 across 276 interventional studies indexed under Pneumonia, Ventilator-Associated.
Browse Pneumonia, Ventilator-Associated studies →Postgraduate Medical Institute, Lahore is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Participants must meet all of the following:
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
Any of the following will lead to exclusion:
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive inhaled amikacin administered via nebulization in addition to standard intravenous antibiotic therapy for ventilator-associated pneumonia. Therapy continues for the prescribed antibiotic course and according to unit protocol.
Drug: Amikacin (Inhalation) · Drug: Standard-of-Care Intravenous Antibiotics
Participants will receive only standard intravenous antibiotic therapy for ventilator-associated pneumonia. Therapy continues for the prescribed antibiotic course and according to unit protocol.
Drug: Standard-of-Care Intravenous Antibiotics
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.
Intravenous antibiotics selected based on local antimicrobial guidelines and pathogen sensitivity for ventilator-associated pneumonia, administered for the full
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
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in this article may be shared upon reasonable request from qualified researchers.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Beginning 12 months after publication of study results, with no planned end date.
Access criteria: Requests must include a methodologically sound proposal and will require approval by the Institutional Review Committee and execution of a data sharing agreement.
Data sharing details ↗ · sites.google.com
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Amikacin
Pneumonia, Ventilator-Associated →
Postgraduate Medical Institute, Lahore