Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan) (RESCUE-L)
To collect retrospectively the efficacy and safety information of azithromycin IV on patients with Legionnaires' disease related to their appropriate use in daily practice.
Legionella Pneumophila Infections
Drug: Azithromycin IV
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Research Of Effectiveness And Safety On Patients With Legionella Pneumophila Infections, Continuous Treatment With Azithromycin IV And Tab Utilized As The First Administrative Evaluation for Legionnaires' Disease (RESCUE-L)|
- Number of Participants with Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: 29 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Subjects who are treated with Azithromycin IV for Legionnaires' disease
Drug: Azithromycin IV
The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7- to 10-day course of therapy.
The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy.
Other Name: Zithromac IV
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784770
|Study Director:||Pfizer CT.gov Call Center||Pfizer|