Trial | NCT00610623  Report issue

Title

Azithromycin as a Quorum-Sensing Inhibitor for the Prevention of Pseudomonas Aeruginosa Ventilator-Associated Pneumonia
Proof of Concept Study to Investigate the Impact of Azithromycin Administered iv Versus Placebo on the Prevention of Pneumonia in Ventilated Patients Colonized by Pseudomonas Aeruginosa

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    azithromycin ...

  • Study Participants

    92
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.
Study Started
Apr 30
2003
Primary Completion
Oct 31
2005
Study Completion
Oct 31
2005
Last Update
Feb 08
2008
Estimate

Drug azithromycin

300 mg/day, IV from day 1 to 20

  • Other names: Zithromax

Drug placebo

once per day, IV from day 1 to 20

1 Experimental

azithromycin iv 300 mg/day

2 Placebo Comparator

Placebo

Criteria 

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
No Results Posted