Overview

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

Status:
Terminated
Trial end date:
2005-10-01
Target enrollment:
0
Participant gender:
All
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 ventilated patients colonized with Pseudomonas aeruginosa.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Anbics Management-Services Ag
Collaborator:
Swiss National Science Foundation
Treatments:
Azithromycin
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