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

Anbics Management-Services

Status and phase: Terminated; Phase 2

Conditions: Pseudomonas Infections; Pneumonia, Ventilator-Associated

Treatments: Drug: azithromycin; Drug: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00610623

Anb006#2001

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

azithromycin iv 300 mg/day

Treatment:

Drug: azithromycin

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo