Azithromycin as a Quorum-Sensing Inhibitor for the Prevention of Pseudomonas Aeruginosa Ventilator-Associated Pneumonia

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2005-10-31

Brief Summary

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The purpose of this study is to assess the clinical efficacy of azithromycin, used as a quorum-sensing blocker, when compared to placebo for preventing or delaying the occurrence of pneumonia in ventilated patients colonized with Pseudomonas aeruginosa.

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Detailed Description

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Conditions

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Pneumonia, Ventilator-Associated Pseudomonas Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

azithromycin iv 300 mg/day

Group Type EXPERIMENTAL

azithromycin

Intervention Type DRUG

300 mg/day, IV from day 1 to 20

2

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

once per day, IV from day 1 to 20

Interventions

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azithromycin

300 mg/day, IV from day 1 to 20

Intervention Type DRUG

placebo

once per day, IV from day 1 to 20

Intervention Type DRUG

Other Intervention Names

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Zithromax

Eligibility Criteria

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Inclusion Criteria

* Male and non pregnant female aged 18 to 75 years
* Patients hospitalized in ICU, under mechanically assisted ventilation expected to be mandatory for 3 days or more
* Reasonable survival chance within next few days with an Apache score 10-25
* Tracheal aspirate found positive for P. aeruginosa
* The subject (or a close family member in case of incompetence) understands the procedure, agrees to participate, and is willing to give written informed consent
* Informed consent must be obtained for all subjects before enrollment in the study, by patient or by a close family member

Exclusion Criteria

* Poor prognosis as judged by Apache score II score \>25
* Pregnant female
* Grossly under-or overweight (BMI\<18or \>29)
* Ongoing therapy with a macrolide
* Known allergy to any macrolide
* Proven P. aeruginosa pneumonia
* Ongoing anti-pseudomonal therapy with a proven susceptible colonizing strain
* Anticipated short duration of mechanical ventilation (\<3 days)
* Known drug interaction that could either decrease efficacy or raise safety concerns
* Severe hepatic failure (type C, score \>10 on Child Pugh scale)
* Sick sinus syndrome or long QT syndrome
* Recent donation of blood or participation in another clinical trial within 3 months
* Any situation exposing the patient to higher risk or possibly confounding results

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No