Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit

Early Phase 1

Completed

• Conditions: Respiratory Infection; Bacterial Resistance; Respiratory Failure
• Interventions: Drug: Placebo; Drug: vancomycin or gentamicin

• Registration Number: NCT01878643
• Lead Sponsor: Stony Brook University

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

Study Timeline

• Study Start: 2001-12
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Status Verified: 2013-06
• Study First Submitted: 2013-06-07
• Study First Submitted QC: 2013-06-12
• Last Update Submitted: 2013-06-12
• Study First Posted: 2013-06-17
• Last Update Posted: 2013-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: Placebo	Placebo	normal saline 2 mL nebulized Q 8 hours placebo for gentamicin or vancomycin
Drug: vancomycin or gentamicin	vancomycin or gentamicin	vancomycin 120 mg every 8 hours or gentamicin 80 mg every 8 hours

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Medical Center; 🇺🇸 STony Brook, New York, United States