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

Brief 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.

Condition or disease Intervention/treatment Phase
Pneumonia, Ventilator-Associated Pseudomonas Infections Drug: azithromycin Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : April 2003
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: 1
azithromycin iv 300 mg/day
Drug: azithromycin
300 mg/day, IV from day 1 to 20
Other Name: Zithromax

Placebo Comparator: 2
Drug: placebo
once per day, IV from day 1 to 20

Primary Outcome Measures :
  1. Occurrence of and time to Pseudomonas aeruginosa pneumonia [ Time Frame: daily ]

Secondary Outcome Measures :
  1. occurrence of and time to death [ Time Frame: daily ]
  2. time to extubation [ Time Frame: daily ]
  3. overall outcome [ Time Frame: daily ]
  4. duration of hospitalization and ICU stay [ Time Frame: daily ]
  5. occurrence of infections to other bacterial strains [ Time Frame: daily ]
  6. cost assessment [ Time Frame: daily ]
  7. demonstrate using in vitro and in vivo parameters that azithromycin can be used as a quorum-sensing blocker against P. aeruginosa [ Time Frame: daily ]
  8. determine whether prolonged treatment with azithromycin may induce resistance to any of 11 anti-pseudomonal antibiotics [ Time Frame: daily ]
  9. determine whether P. aeruginosa can develop resistance to the quorum-sensing effect of azithromycin [ Time Frame: daily ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00610623

Intensive Care Unit, Clinique Saint-Pierre
Ottignies, Louvain, Belgium, 1340
General Intensive Car Unit, Centre Hospitalier Universitaire de Liège
Liège, Belgium, B-4000
Former Serbia and Montenegro
Surgical Intensive Care Unit, Clinical Center of Serbia, Institut of Neurosurgery
Belgrade, Former Serbia and Montenegro
Surgical Intensive Care Unit, Clinical Center of Serbia
Belgrade, Former Serbia and Montenegro
Intensive Care Unit, Jean Minjoz University Hospital
Besancon, France, 25030
Intensive Car Unit, Calmette University Hospital of Lille
Lille, France, 59037
Medical-surgical intensive car unit, Dupuytren Teaching Hospital
Limoges, France, 8700
General Intensive Care Unit, Montauban City Hospital
Montauban, France, 82013
Medical Intensive Car Unit, Hospital Bichat
Paris, France, 75018
Surgical Intensive Car Unit; University Hospital Bichat
Paris, France, 75018
General Intensive Care Unit, Hospital Saint-Joseph
Paris, France, 75674
Medical Intensive Care Unit, Cochin Hospital
Paris, France, 75679
Intensive Care Unit, Wojewodzki Hospital
Krakow, Poland
Intensive Care Unit, Wojewodzki Hospital
Sosnowiec, Poland
Intensive Care Unit, Central Hospital
Warsaw, Poland
Intensive Care Unit, Hospital del Mar
Barcelona, Spain, 08003
Internal Medicine, Vall d'Hebron Hospital
Barcelona, Spain, 08035
Intensive Care Unit, San Dureta University Hospital
Palma de Mallorca, Spain, 07014
Intensive Care Unit, Joan XXIII University Hospital
Tarragona, Spain, 43007
Surgical and Medical Intensive Care Units, University Hospital Lausanne
Lausanne, Vaud, Switzerland
Sponsors and Collaborators
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christian van Delden, Service of Infectious Diseases, University Hospital Geneva Identifier: NCT00610623     History of Changes
Other Study ID Numbers: Anb006#2001
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: February 8, 2008
Last Verified: January 2008

Keywords provided by Anbics Management-Services Ag:
Pseudomonas aeruginosa
Quorum Sensing

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Pseudomonas Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury
Gram-Negative Bacterial Infections
Bacterial Infections