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

Anbics Management-Services Ag19 sites in 6 countries92 target enrollmentApril 2003

ConditionsPneumonia, Ventilator-Associated Pseudomonas Infections

Interventionsazithromycin placebo

Drugsazithromycin placebo

Overview

Phase: Phase 2
Intervention: azithromycin
Conditions: Pneumonia, Ventilator-Associated
Sponsor: Anbics Management-Services Ag
Enrollment: 92
Locations: 19
Primary Endpoint: Occurrence of and time to Pseudomonas aeruginosa pneumonia
Status: Terminated
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2003

End Date

October 2005

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Anbics Management-Services Ag

Eligibility 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)

Arms & Interventions

1

azithromycin iv 300 mg/day

Intervention: azithromycin

2

Placebo

Intervention: placebo

Outcomes

Primary Outcomes

Occurrence of and time to Pseudomonas aeruginosa pneumonia

Time Frame: daily

Secondary Outcomes

occurrence of and time to death(daily)
time to extubation(daily)
overall outcome(daily)
duration of hospitalization and ICU stay(daily)
occurrence of infections to other bacterial strains(daily)
cost assessment(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)