Azithromycin as a Quorum-Sensing Inhibitor for the Prevention of Pseudomonas Aeruginosa Ventilator-Associated Pneumonia
- Conditions
- Pneumonia, Ventilator-AssociatedPseudomonas Infections
- Interventions
- Drug: placebo
- Registration Number
- NCT00610623
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 92
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 azithromycin azithromycin iv 300 mg/day 2 placebo Placebo
- Primary Outcome Measures
Name Time Method Occurrence of and time to Pseudomonas aeruginosa pneumonia daily
- Secondary Outcome Measures
Name Time Method occurrence of infections to other bacterial strains daily cost assessment daily occurrence of and time to death daily time to extubation daily overall outcome daily duration of hospitalization and ICU stay daily demonstrate using in vitro and in vivo parameters that azithromycin can be used as a quorum-sensing blocker against P. aeruginosa daily determine whether prolonged treatment with azithromycin may induce resistance to any of 11 anti-pseudomonal antibiotics daily determine whether P. aeruginosa can develop resistance to the quorum-sensing effect of azithromycin daily
Trial Locations
- Locations (19)
Intensive Care Unit, Clinique Saint-Pierre
🇧🇪Ottignies, Louvain, Belgium
General Intensive Car Unit, Centre Hospitalier Universitaire de Liège
🇧🇪Liège, Belgium
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
Intensive Car Unit, Calmette University Hospital of Lille
🇫🇷Lille, France
Medical-surgical intensive car unit, Dupuytren Teaching Hospital
🇫🇷Limoges, France
General Intensive Care Unit, Montauban City Hospital
🇫🇷Montauban, France
Medical Intensive Car Unit, Hospital Bichat
🇫🇷Paris, France
Surgical Intensive Car Unit; University Hospital Bichat
🇫🇷Paris, France
Scroll for more (9 remaining)Intensive Care Unit, Clinique Saint-Pierre🇧🇪Ottignies, Louvain, Belgium