Clinical Outcomes of Inhaled Amikacin in Ventilator Associated Pneumonia (RCT)

Postgraduate Medical Institute, Lahore

Status and phase: Completed; Phase 4

Conditions: Ventilator Associated Pneumonia ( VAP)

Treatments: Drug: Amikacin (Inhalation); Drug: Standard-of-Care Intravenous Antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT07369336

LGH/PGMI/AMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Inhaled Amikacin + Standard-of-Care Antibiotics

Experimental group

Description:

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.

Treatment:

Drug: Standard-of-Care Intravenous Antibiotics

Drug: Amikacin (Inhalation)

Participants will receive ONLY standard of care antibiotics

Active Comparator group

Description:

Participants will receive only standard intravenous antibiotic therapy for ventilator-associated pneumonia. Therapy continues for the prescribed antibiotic course and according to unit protocol.

Treatment:

Drug: Standard-of-Care Intravenous Antibiotics