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

Information source: Stony Brook University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Respiratory Infection; Bacterial Resistance; Respiratory Failure

Intervention: vancomycin or gentamicin (Drug); Placebo (Drug)

Phase: Phase 0

Status: Completed

Sponsored by: Stony Brook University

Official(s) and/or principal investigator(s):
Lucy B Palmer, MD, Principal Investigator, Affiliation: Stony Brook University

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

Clinical Details

Official title: Pilot Study of the Effects of Inhaled Antibiotic on Bacterial Resistance

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Eradication of multi-drug resistant bacteria

Secondary outcome: Clinical Pulmonary Infection Score (CPIS)

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University Hospital Medical Center, STony Brook, New York 11794, United States
Additional Information

Starting date: December 2001
Last updated: June 12, 2013

Page last updated: August 23, 2015

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