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

Early Phase 1CompletedNCT01878643

Stony Brook University47 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Respiratory Infection Bacterial Resistance Respiratory Failure

Interventions

vancomycin or gentamicinDRUG

Choice of antibiotic is determined by Gram stain of sputum.The antibiotic is administered via nebulization through the ventilator circuit every 8 hours

PlaceboDRUG

normal saline administered to patient via nebulization

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Medical Center

Stony Brook, New York, United States

Outcomes

Primary Outcomes

Eradication of multi-drug resistant bacteria

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.

Time frame: Randomization and at end of treatment

Secondary Outcomes

Clinical Pulmonary Infection Score (CPIS)

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

Time frame: Randomization and at end of treatment which is defined as 14 days or at time of extubation, which ever comes first.

Data from ClinicalTrials.gov

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