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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00610623
Recruitment Status : Terminated (The sponsor decided to stop the study prematurely because of financial issues)
First Posted : February 8, 2008
Last Update Posted : February 8, 2008
Swiss National Science Foundation
Information provided by:
Anbics Management-Services Ag

January 24, 2008
February 8, 2008
February 8, 2008
April 2003
October 2005   (Final data collection date for primary outcome measure)
Occurrence of and time to Pseudomonas aeruginosa pneumonia [ Time Frame: daily ]
Same as current
No Changes Posted
  • occurrence of and time to death [ Time Frame: daily ]
  • time to extubation [ Time Frame: daily ]
  • overall outcome [ Time Frame: daily ]
  • duration of hospitalization and ICU stay [ Time Frame: daily ]
  • occurrence of infections to other bacterial strains [ Time Frame: daily ]
  • cost assessment [ Time Frame: daily ]
  • demonstrate using in vitro and in vivo parameters that azithromycin can be used as a quorum-sensing blocker against P. aeruginosa [ Time Frame: daily ]
  • determine whether prolonged treatment with azithromycin may induce resistance to any of 11 anti-pseudomonal antibiotics [ Time Frame: daily ]
  • determine whether P. aeruginosa can develop resistance to the quorum-sensing effect of azithromycin [ Time Frame: daily ]
Same as current
Not Provided
Not Provided
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
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Pneumonia, Ventilator-Associated
  • Pseudomonas Infections
  • Drug: azithromycin
    300 mg/day, IV from day 1 to 20
    Other Name: Zithromax
  • Drug: placebo
    once per day, IV from day 1 to 20
  • Experimental: 1
    azithromycin iv 300 mg/day
    Intervention: Drug: azithromycin
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Köhler T, Perron GG, Buckling A, van Delden C. Quorum sensing inhibition selects for virulence and cooperation in Pseudomonas aeruginosa. PLoS Pathog. 2010 May 6;6(5):e1000883. doi: 10.1371/journal.ppat.1000883.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2005
October 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Former Serbia and Montenegro,   France,   Poland,   Spain,   Switzerland
Not Provided
Not Provided
Christian van Delden, Service of Infectious Diseases, University Hospital Geneva
Anbics Management-Services Ag
Swiss National Science Foundation
Principal Investigator: Christian Van Delden, MD Service of Infectious Diseases, University Hospital Geneva, Switzerland
Study Chair: Jean Carlet, MD General Intensive Care Unit, Hospital Saint-Joseph, Paris, France
Anbics Management-Services Ag
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP