Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation

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

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2004-09-30

Brief Summary

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The purpose of this study was to determine the effect of aerosolized antibiotics on respiratory infection in mechanically ventilated patients.We hypothesize that aerosolized antibiotics , which achieve high drug concentrations in the airway, would more effectively treat respiratory infection, decrease the need for systemic antibiotics and decrease antibiotic resistance.

Detailed Description

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In patients requiring mechanical ventilation, signs of respiratory infection often persist despite treatment with powerful antibiotics given through the patient's vein. In this trial, patients with purulent secretions were assigned aerosolized antibiotics or placebo by a randomizing protocol. Neither the patients or their doctors knew what the patient was receiving.Need for a systemic antibiotic was determined by the clinical physician. Comparisons were made between placebo and study drug for their effects on pneumonia, respiratory signs of infection, ability to wean patients from the ventilator, systemic(given in the vein) antibiotic use and the development of organisms that were resistant to antibiotics.

Conditions

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Ventilator Associated Pneumonia Respiratory Infection Tracheobronchitis

Keywords

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aerosolized antibiotics ventilator associated pneumonia clinical pulmonary infection score bacterial resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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aerosolized vancomycin or gentamicin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* be on mechanical ventilation greater than 3 days
* greater than or equal to 18 years of age survival greater than 14 days
* greater than 2 ccs of tracheal secretions/4 hours

Exclusion Criteria

* allergy to drugs, pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Lucy B Palmer, MD

Role: PRINCIPAL_INVESTIGATOR

SUNY at Stony Brook

Locations

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University Hospital Medical Center

Stony Brook, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CORIHS # 2004-3799

Identifier Type: -

Identifier Source: org_study_id