Clinical Trial: Drug Use Investigation Of Azithromycin IV For Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan)

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

Official Title: Drug Use Investigation Of Azithromycin Iv

Brief Summary: To collect the efficacy and safety information of Azithromycin IV related to their appropriate use in daily practice

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Number of Participants With Treatment-Related Adverse Events [ Time Frame: 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 (and Zithromac Tablets). 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.


Original Primary Outcome: Number of Participants with Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: 29 days ]

Current Secondary Outcome:

  • Clinical Effectiveness Rate in Participants With Pneumonia [ Time Frame: 29 days ]
    Clinical effectiveness rate in participants with pneumonia, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with pneumonia, 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.
  • Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease [ Time Frame: 29 days ]
    Clinical effectiveness rate in pelvic inflammatory disease (PID), which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with PID, 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.


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

Information By: Pfizer

Dates:
Date Received: August 20, 2012
Date Started: September 20, 2012
Date Completion:
Last Updated: March 15, 2017
Last Verified: March 2017