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