Official Title: “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”

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 Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2005

Intervention(s) in this Clinical Trial

• Drug: azithromycin
  • 300 mg/day, IV from day 1 to 20
• Drug: placebo
  • once per day, IV from day 1 to 20

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • azithromycin iv 300 mg/day
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Occurrence of and time to Pseudomonas aeruginosa pneumonia
  • Time Frame: daily
    Safety Issue?: No

Secondary Measures

• occurrence of and time to death
  • Time Frame: daily
    Safety Issue?: Yes
• time to extubation
  • Time Frame: daily
    Safety Issue?: No
• overall outcome
  • Time Frame: daily
    Safety Issue?: Yes
• duration of hospitalization and ICU stay
  • Time Frame: daily
    Safety Issue?: No
• occurrence of infections to other bacterial strains
  • Time Frame: daily
    Safety Issue?: Yes
• cost assessment
  • Time Frame: daily
    Safety Issue?: No
• demonstrate using in vitro and in vivo parameters that azithromycin can be used as a quorum-sensing blocker against P. aeruginosa
  • Time Frame: daily
    Safety Issue?: No
• determine whether prolonged treatment with azithromycin may induce resistance to any of 11 anti-pseudomonal antibiotics
  • Time Frame: daily
    Safety Issue?: Yes
• determine whether P. aeruginosa can develop resistance to the quorum-sensing effect of azithromycin
  • Time Frame: daily
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Anbics Management-Services Ag

Overall Clinical Trial Officials and Contacts

Christian Van Delden, MD Principal Investigator Service of Infectious Diseases, University Hospital Geneva, Switzerland  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00610623

Study ID Number: Anb006#2001

ClinicalTrials.gov Identifier: NCT00610623

Health Authority: Switzerland: Swissmedic