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 ]
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