Azithromycin as a Quorum-Sensing Inhibitor for the Prevention of Pseudomonas Aeruginosa Ventilator-Associated Pneumonia
Information source: Anbics Management-Services Ag
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia, Ventilator-Associated; Pseudomonas Infections
Intervention: azithromycin (Drug); placebo (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Anbics Management-Services Ag Official(s) and/or principal investigator(s):
Christian Van Delden, MD, Principal Investigator, Affiliation: Service of Infectious Diseases, University Hospital Geneva, Switzerland
Jean Carlet, MD, Study Chair, Affiliation: General Intensive Care Unit, Hospital Saint-Joseph, Paris, France
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.
Clinical Details
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 design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Occurrence of and time to Pseudomonas aeruginosa pneumonia
Secondary outcome: occurrence of and time to deathtime to extubation overall outcome duration of hospitalization and ICU stay occurrence of infections to other bacterial strains cost assessment demonstrate using in vitro and in vivo parameters that azithromycin can be used as a quorum-sensing blocker against P. aeruginosa determine whether prolonged treatment with azithromycin may induce resistance to any of 11 anti-pseudomonal antibiotics determine whether P. aeruginosa can develop resistance to the quorum-sensing effect of azithromycin
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
General Intensive Car Unit, Centre Hospitalier Universitaire de Liège, Liège B-4000, Belgium
Intensive Care Unit, Jean Minjoz University Hospital, Besancon 25030, France
Intensive Car Unit, Calmette University Hospital of Lille, Lille 59037, France
Medical-surgical intensive car unit, Dupuytren Teaching Hospital, Limoges 8700, France
General Intensive Care Unit, Montauban City Hospital, Montauban 82013, France
Surgical Intensive Car Unit; University Hospital Bichat, Paris 75018, France
General Intensive Care Unit, Hospital Saint-Joseph, Paris 75674, France
Medical Intensive Care Unit, Cochin Hospital, Paris 75679, France
Medical Intensive Car Unit, Hospital Bichat, Paris 75018, France
Intensive Care Unit, Wojewodzki Hospital, Sosnowiec, Poland
Intensive Care Unit, Central Hospital, Warsaw, Poland
Intensive Care Unit, Wojewodzki Hospital, Krakow, Poland
Surgical Intensive Care Unit, Clinical Center of Serbia, Belgrade, Serbia and Montenegro
Surgical Intensive Care Unit, Clinical Center of Serbia, Institut of Neurosurgery, Belgrade, Serbia and Montenegro
Intensive Care Unit, San Dureta University Hospital, Palma de Mallorca 07014, Spain
Intensive Care Unit, Hospital del Mar, Barcelona 08003, Spain
Internal Medicine, Vall d'Hebron Hospital, Barcelona 08035, Spain
Intensive Care Unit, Joan XXIII University Hospital, Tarragona 43007, Spain
Intensive Care Unit, Clinique Saint-Pierre, Ottignies, Louvain 1340, Belgium
Surgical and Medical Intensive Care Units, University Hospital Lausanne, Lausanne, Vaud, Switzerland
Additional Information
Starting date: April 2003
Ending date: October 2005
Last updated: January 28, 2008
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