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

Completed

• Conditions: Legionnaires' Disease; Legionella Pneumophila Infections
• Interventions: Drug: Azithromycin IV

• Registration Number: NCT01784770
• Lead Sponsor: Pfizer

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 Description

Not available

Study Timeline

• Study First Submitted: 2013-02-04
• Study First Submitted QC: 2013-02-04
• Study First Posted: 2013-02-06
• Study Start: 2013-03-27
• Primary Completion: 2016-07-29
• Study Completion: 2016-07-29
• Status Verified: 2017-07
• Results First Submitted: 2017-07-06
• Results First Submitted QC: 2017-07-06
• Last Update Submitted: 2017-07-06
• Results First Posted: 2017-11-30
• Last Update Posted: 2017-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• All patients who are prescribed Azithromycin (Zithromac) IV for Legionnaires' disease.

Exclusion Criteria

• Patients who have been prescribed Zithromac or Zithromac SR.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Azithromycin IV	Azithromycin IV	Subjects who are treated with Azithromycin IV for Legionnaires' disease

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Related Adverse Events	29 days	A treatment-related adverse event was any untoward medical occurrence attributed to Zithromac Intravenous use (and Zithromac Tablets) in a participant who received Zithromac Intravenous use. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Zithromac Intravenous use (and Zithromac Tablets) was assessed by the physician.

Secondary Outcome Measures

Name	Time	Method
Clinical Effectiveness Rate in Participants	29 days	Clinical effectiveness rate in participants, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.