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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
History of Changes
  Purpose

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 Intervention Phase
Pneumonia, Ventilator-Associated
Pseudomonas Infections
 Drug: azithromycin
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by Anbics Management-Services Ag:

Primary Outcome Measures:
  • Occurrence of and time to Pseudomonas aeruginosa pneumonia [ Time Frame: daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 92
Study Start Date: April 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
azithromycin iv 300 mg/day
 Drug: azithromycin
300 mg/day, IV from day 1 to 20
Other Name: Zithromax
Placebo Comparator: 2
Placebo
 Drug: placebo
once per day, IV from day 1 to 20

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610623

Locations
Belgium
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
Belgrade, Former Serbia and Montenegro
Surgical Intensive Care Unit, Clinical Center of Serbia, Institut of Neurosurgery
Belgrade, Former Serbia and Montenegro
France
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 Care Unit, Cochin Hospital
Paris, France, 75679
Medical Intensive Car Unit, Hospital Bichat
Paris, France, 75018
General Intensive Care Unit, Hospital Saint-Joseph
Paris, France, 75674
Surgical Intensive Car Unit; University Hospital Bichat
Paris, France, 75018
Poland
Intensive Care Unit, Wojewodzki Hospital
Krakow, Poland
Intensive Care Unit, Wojewodzki Hospital
Sosnowiec, Poland
Intensive Care Unit, Central Hospital
Warsaw, Poland
Spain
Internal Medicine, Vall d'Hebron Hospital
Barcelona, Spain, 08035
Intensive Care Unit, Hospital del Mar
Barcelona, Spain, 08003
Intensive Care Unit, San Dureta University Hospital
Palma de Mallorca, Spain, 07014
Intensive Care Unit, Joan XXIII University Hospital
Tarragona, Spain, 43007
Switzerland
Surgical and Medical Intensive Care Units, University Hospital Lausanne
Lausanne, Vaud, Switzerland
Sponsors and Collaborators
Anbics Management-Services Ag
Swiss National Science Foundation
Investigators
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
  More Information

No publications provided by Anbics Management-Services Ag

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christian van Delden, Service of Infectious Diseases, University Hospital Geneva
ClinicalTrials.gov Identifier: NCT00610623     History of Changes
Other Study ID Numbers: Anb006#2001
Study First Received: January 24, 2008
Last Updated: January 28, 2008
Health Authority: Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Pneumonia
Pseudomonas Infections
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Cross Infection
 Infection
Ventilator-Induced Lung Injury
Lung Injury
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013