Ventilator-associated pneumonia caused by resistant Gram-negative bacteria. Pneumonia due to other aerobic Gram-negative bacteria
Conditions
Interventions
Intervention 1: Intervention group: Nebulized amikacin at a dose of 400 mg every 12 hours for 5 days, administered using a vibrating mesh nebulizer connected to the ventilator circuit. Intervention 2:
Sponsors
Ahvaz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age 18 years or older Admitted to ICU Receiving invasive mechanical ventilation for at least 48 hours Diagnosis of hospital-acquired pneumonia or VAP based on clinical, radiological, and microbiological criteria Positive sputum or BAL culture for Gram-negative bacteria CPIS score compatible with pneumonia
Exclusion criteria
Exclusion criteria: Creatinine clearance less than 30 mL/min History of hypersensitivity to aminoglycosides or amikacin Pregnancy or breastfeeding Concurrent participation in other interventional clinical trials Presence of a do-not-resuscitate (DNR) or treatment-limitation order Occurrence of severe drug-related adverse events during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of nephrotoxicity based on KDIGO criteria. Timepoint: Day 0, Day 3, Day 5, then every 48 hours until discharge. Method of measurement: Serum creatinine, urine output monitoring, and KDIGO classification.;Development of aminoglycoside-related ototoxicity. Timepoint: Day 0 and Day 5. Method of measurement: Audiometry or otoacoustic emission testing; clinical auditory assessment when needed.;Emergence of new antimicrobial resistance in follow-up cultures. Timepoint: Day 0, Day 3, and Day 5. Method of measurement: Microbiological culture and susceptibility testing.;Clinical improvement of pneumonia defined as a decrease of =2 points in the CPIS score from baseline or achieving CPIS < 6. Timepoint: Day 0 (baseline) and Day 5 of treatment. Method of measurement: Assessment of CPIS score including temperature, WBC count, PaO2/FiO2 ratio, tracheal secretions, chest radiograph, and microbiological culture results.;Microbiological eradication defined as negative tracheal aspirate/BAL culture or significant reduction of resistant Gram-negative bacterial load. Timepoint: Baseline (Day 0), Day 3, and Day 5. Method of measurement: BAL or tracheal aspirate culture with antimicrobial susceptibility testing.;Serum and ELF concentrations of amikacin and PK/PD indices (e.g., AUC/MIC). Timepoint: Day 1 and Day 3 with multiple sampling points. Method of measurement: Amikacin quantification using HPLC or validated assays; PK analysis using non-compartmental methods.;Change in CPIS score from baseline during treatment. Timepoint: Day 0, Day 3, and Day 5. Method of measurement: CPIS scoring using clinical, radiological, and laboratory parameters.;Number of days on mechanical ventilation after initiating therapy. Timepoint: From Day 0 until successful liberation from the ventilator. Method of measurement: Daily documentation from patient medical records.;Length of ICU stay after initiation of treatment. Timepoint: Day 0 until ICU discharge. Method of measurement: Extraction from | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahbobeh Rashidi
Ahvaz University of Medical Sciences
Outcome results
None listed