Ventilator Associated Pneumonia ( VAP)
Conditions
Keywords
Ventilator associated pneumonia, Inhaled amikacin, Mechanical ventilation, Adjunctive therapy, Clinical improvement
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.
Detailed 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.
Interventions
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.
DRUGStandard-of-Care Intravenous Antibiotics
Intravenous antibiotics selected based on local antimicrobial guidelines and pathogen sensitivity for ventilator-associated pneumonia, administered for the full
Sponsors
Postgraduate Medical Institute, Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking was applied. Due to nature of treatmeht, both the treating clinicians and participants, representatives were aware of the assigned treatment.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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/attendant
Exclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of invasive mechanical ventilation | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Improvement on Day 7 | 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. |
Countries
Pakistan
Outcome results
None listed