Pilot Study of the Effects of Inhaled Antibiotic on Bacterial Resistance
Overview
- Phase
- Early Phase 1
- Intervention
- vancomycin or gentamicin
- Conditions
- Respiratory Infection
- Sponsor
- Stony Brook University
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Eradication of multi-drug resistant bacteria
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Drug: vancomycin or gentamicin
vancomycin 120 mg every 8 hours or gentamicin 80 mg every 8 hours
Intervention: vancomycin or gentamicin
Drug: Placebo
normal saline 2 mL nebulized Q 8 hours placebo for gentamicin or vancomycin
Intervention: Placebo
Outcomes
Primary Outcomes
Eradication of multi-drug resistant bacteria
Time Frame: 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 Outcomes
- 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.)