Bacterial Resistance, Respiratory Failure, Respiratory Infection
Conditions
Keywords
aerosolized antibiotic, ventilator-associated pneumonia, bacterial resistance, ventilator -associated tracheobronchitis, clinical pulmonary infection score
Brief summary
The purpose of this study was : * to determine the effect of inhaled antibiotics on airway bacteria in ventilated patients * to determine the effect of inhaled antibiotics on respiratory infection
Detailed description
Double-blind randomized placebo controlled study examining the effect of aerosolized antibiotics on respiratory infection signs and symptoms and on bacterial eradication and resistance. Systemic antibiotics are administered by the responsible physician
Interventions
DRUGvancomycin or gentamicin
Choice of antibiotic is determined by Gram stain of sputum.The antibiotic is administered via nebulization through the ventilator circuit every 8 hours
DRUGPlacebo
normal saline administered to patient via nebulization
Sponsors
Stony Brook 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
* be on mechanical ventilation greater than 3 days * greater than or equal to 18 years and survival greater than 14 days * organisms on Gram stain with increasing purulent secretions
Exclusion criteria
* pregnancy * allergy to drugs administered
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication of multi-drug resistant bacteria | Randomization and at end of treatment | Tracheal aspirates are taken at randomization. Randomization to drug is determined by the Gram stain(organisms are Gram-positive, Gram-negative or both). End of treatment culture, susceptibility and Gram stain of tracheal aspirate is taken after 14 days of treatment or at time of extubation, (which ever comes first). Eradication is defined as absence of growth in culture and absence of organisms on Gram stain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pulmonary Infection Score (CPIS) | Randomization and at end of treatment which is defined as 14 days or at time of extubation, which ever comes first. | CPIS is an index for risk of respiratory infection using a number of signs and symptoms . An index of greater than or equal to 6 suggests pneumonia |
Countries
United States
Outcome results
None listed