Clinical Trial: Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Zithromac Iv Special Investigation For Legionella Infection.

Brief Summary: To collect retrospectively the efficacy and safety information of azithromycin IV on patients with Legionnaires' disease related to their appropriate use in daily practice.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Number of Participants with Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: 29 days ]

The clinical response was assigned by the investigator. A clinical response of cure was defined as: Test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. Test-of-cure performed 10-28 days after last dose of study drug.


Original Primary Outcome: Number of Participants with Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: 29 days ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Pfizer

Dates:
Date Received: February 4, 2013
Date Started: March 2013
Date Completion:
Last Updated: February 23, 2017
Last Verified: February 2017