Pneumonia, Ventilator-Associated
Conditions
Brief summary
The purpose of this study is to determine the cure rate from ventilator-associated pneumonia (VAP) caused by Gram negative bacteria when administering add on nebulized amikacin to intravenous antibiotics compared to intravenous antibiotics alone.
Detailed description
After inclusion, the patients are randomized into two groups: nebulized amikacin plus intravenous antibiotic(s) or nebulized placebo plus intravenous antibiotic(s). The dose of nebulized amikacin is 400 mg every 12 hours for 10 days. The patients are followed up on day 3, 7, 10, and 28 for safety and efficacy. The estimate sample size is 84 subjects base on previous study of cure rate in VAP and the authors expected that nebulized amikacin can improve cure rate in VAP subjects for 30% when compared with intravenous antibiotic(s) alone with power of 80% at level of significance 0.05.
Interventions
DRUGAmikacin
400 mg, nebulizer, every 12 hours, 10 days
DRUGPlacebo
placebo 4 ml, nebulizer, every 12 hours, 10 days
Sponsors
Thammasat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>/= 18 years * On mechanical ventilator more than 7 days * VAP diagnosis inclusion criteria: 1. new/progressive infiltration of chest radiography 2. 2/3 of the following: 1) fever 2) purulent sputum 3) Wbc \> 12,000 cell/mm3 or \< 4,000 cell/mm3 * Evidence of gram negative bacilli from sputum gram stain or previous sputum culture within 1 week
Exclusion criteria
* History of amikacin allergy * GFR \< 30 mL/min except dialytic patients * Immunocompromised host: HIV CD4 \< 200 cells/mm3, leukemia, lymphoma, received chemotherapy within 3 weeks, Absolute neutrophil count \< 500/mm3 * Severe ARDS (P/F ratio \< 100) * Endobronchial obstruction:endobronchial mass, endobronchial stenosis * Atelectasis * Severe bronchospasm * Lung abscess * Complicated parapneumonic effusion/ Empyema * Chest trauma * Uncontrolled extrapulmonary infection(s) * Received intravenous antibiotic(s) more than 48 hours * Pregnancy/ Lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cure rate | 10 days after end of the intervention | Cure rate = improvement/ no new infiltration of chest radiography plus 2/3 of the following: 1) No fever within 48 hours after end of the intervention 2) The reduction of secretion 3) The reduction of white blood cell |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality rate | at 28 days after end of the intervention | All causes of death during the intervention |
| duration of mechanical ventilation | at 28 days after end of the intervention | number of days on mechanical ventilation |
| The reduction of pathogens | 10 days after end of the intervention | quantitative sputum cultures were measured every days for 10 days or no growth of organism. |
| duration of hospitalization | at 28 days after end of the intervention | number of days hospitalization |
| Safety of intervention drug | at 28 days after end of the intervention | Any adverse events were recorded |
| duration of ICU stay | at 28 days after end of the intervention | number of ICU days |
Countries
Thailand
Outcome results
None listed