Clinical Trial: Azithromycin as a Quorum-Sensing Inhibitor for the Prevention of Pseudomonas Aeruginosa Ventilator-Associated Pneumonia
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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
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 Summary:
Sponsor: Anbics Management-Services Ag
Current Primary Outcome: Occurrence of and time to Pseudomonas aeruginosa pneumonia [ Time Frame: daily ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- occurrence of and time to death [ Time Frame: daily ]
- time to extubation [ Time Frame: daily ]
- overall outcome [ Time Frame: daily ]
- duration of hospitalization and ICU stay [ Time Frame: daily ]
- occurrence of infections to other bacterial strains [ Time Frame: daily ]
- cost assessment [ Time Frame: daily ]
- demonstrate using in vitro and in vivo parameters that azithromycin can be used as a quorum-sensing blocker against P. aeruginosa [ Time Frame: daily ]
- determine whether prolonged treatment with azithromycin may induce resistance to any of 11 anti-pseudomonal antibiotics [ Time Frame: daily ]
- determine whether P. aeruginosa can develop resistance to the quorum-sensing effect of azithromycin [ Time Frame: daily ]
Original Secondary Outcome: Same as current
Information By: Anbics Management-Services Ag
Dates:
Date Received: January 24, 2008
Date Started: April 2003
Date Completion:
Last Updated: January 28, 2008
Last Verified: January 2008
