Clinical Outcomes of Inhaled Amikacin in Ventilator Associated Pneumonia

NCT07369336 | Completed Phase 4

• 1 other identifier: LGH/PGMI/AMC
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventilator Associated Pneumonia ( VAP)

Keywords

Ventilator associated pneumonia; Inhaled amikacin; Mechanical ventilation; Adjunctive therapy; Clinical improvement

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Clinical Improvement on Day 7

  Day 7 after initiation of study treatment

Study Arms (2)

Inhaled Amikacin + Standard-of-Care Antibiotics

EXPERIMENTAL

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 of care antibiotics

ACTIVE COMPARATOR

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

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.

Inhaled Amikacin + Standard-of-Care Antibiotics

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

Inhaled Amikacin + Standard-of-Care Antibiotics; Participants will receive ONLY standard of care antibiotics

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Postgraduate Medical Institute, Lahore: lead

Study Sites (1)

Lahore General Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Links

• https://sites.google.com/view/inhaled-amikacin-vap-data

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Amikacin; Inhalation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was applied. Due to nature of treatmeht, both the treating clinicians and participants, representatives were aware of the assigned treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Anaesthesia/ICU

Model Details: Participants were randomized into two independent parallel groups.One group received standard empirical therapy ie. intravenous antibiotics, while the other group received inhaled amikacin in addition to same intravenous antibiotic regimen. Both groups were treated concurrently without crossover, allowing direct comparison of clinical outcomes between the two treatment strategies.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 27, 2026
• Study Start: January 5, 2024
• Primary Completion: November 25, 2024
• Study Completion: September 30, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

PA (1)