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

NCT ID: NCT01878643

Last Updated: 2013-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2002-12-31

Brief Summary

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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

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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

Conditions

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Respiratory Infection Bacterial Resistance Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Drug: Placebo

normal saline 2 mL nebulized Q 8 hours placebo for gentamicin or vancomycin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

normal saline administered to patient via nebulization

Drug: vancomycin or gentamicin

vancomycin 120 mg every 8 hours or gentamicin 80 mg every 8 hours

Group Type EXPERIMENTAL

vancomycin or gentamicin

Intervention Type DRUG

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

Interventions

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vancomycin 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

Intervention Type DRUG

Placebo

normal saline administered to patient via nebulization

Intervention Type DRUG

Other Intervention Names

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gentamicin sulfate vancomycin hydrocloride Normal saline 2mL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lucy B Palmer, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

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University Hospital Medical Center

Stony Brook, New York, United States

Site Status

Countries

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United States

References

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Palmer LB, Smaldone GC. Reduction of bacterial resistance with inhaled antibiotics in the intensive care unit. Am J Respir Crit Care Med. 2014 May 15;189(10):1225-33. doi: 10.1164/rccm.201312-2161OC.

Reference Type DERIVED
PMID: 24646034 (View on PubMed)

Other Identifiers

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20033799

Identifier Type: -

Identifier Source: org_study_id

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