Status:
TERMINATED
Azithromycin as a Quorum-Sensing Inhibitor for the Prevention of Pseudomonas Aeruginosa Ventilator-Associated Pneumonia
Lead Sponsor:
Anbics Management-Services Ag
Collaborating Sponsors:
Swiss National Science Foundation
Conditions:
Pneumonia, Ventilator-Associated
Pseudomonas Infections
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 venti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00610623
Start Date
April 1 2003
End Date
October 1 2005
Last Update
February 8 2008
Active Locations (20)
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1
General Intensive Car Unit, Centre Hospitalier Universitaire de Liège
Liège, Liège, Belgium, B-4000
2
Intensive Care Unit, Clinique Saint-Pierre
Ottignies, Louvain, Belgium, 1340
3
Intensive Care Unit, Jean Minjoz University Hospital
Besançon, Besancon, France, 25030
4
Intensive Car Unit, Calmette University Hospital of Lille
Lille, Lille, France, 59037