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

This study has been terminated.
(The sponsor decided to stop the study prematurely because of financial issues)
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by:
Anbics Management-Services Ag
ClinicalTrials.gov Identifier:
NCT00610623
First received: January 24, 2008
Last updated: January 28, 2008
Last verified: January 2008

January 24, 2008
January 28, 2008
April 2003
October 2005   (final data collection date for primary outcome measure)
Occurrence of and time to Pseudomonas aeruginosa pneumonia [ Time Frame: daily ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00610623 on ClinicalTrials.gov Archive Site
  • occurrence of and time to death [ Time Frame: daily ] [ Designated as safety issue: Yes ]
  • time to extubation [ Time Frame: daily ] [ Designated as safety issue: No ]
  • overall outcome [ Time Frame: daily ] [ Designated as safety issue: Yes ]
  • duration of hospitalization and ICU stay [ Time Frame: daily ] [ Designated as safety issue: No ]
  • occurrence of infections to other bacterial strains [ Time Frame: daily ] [ Designated as safety issue: Yes ]
  • cost assessment [ Time Frame: daily ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • determine whether prolonged treatment with azithromycin may induce resistance to any of 11 anti-pseudomonal antibiotics [ Time Frame: daily ] [ Designated as safety issue: Yes ]
  • determine whether P. aeruginosa can develop resistance to the quorum-sensing effect of azithromycin [ Time Frame: daily ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
    Placebo
    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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
92
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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Poland,   Spain,   Switzerland,   Former Serbia and Montenegro
 
NCT00610623
Anb006#2001
Yes
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