NCT00871494

Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan

A Multicenter, Non-Randomized, Open Label Study Of Azithromycin Intravenous Followed By Oral Administration In Japanese Adult Subjects With Pelvic Inflammatory Disease (PID) Requiring Initial Intravenous Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Azithromycin had a potent in vitro activities and broad spectrum from typical and atypical bacteria to anaerobes. Azithromycin intravenous formulation demonstrated high efficacy and eradication rate in the western clinical trials. Development of azithromycin intravenous formulation would bring the clinical benefit to patients with pelvic inflammatory disease (PID) in Japan.

Conditions

• Pelvic Inflammatory Disease

Interventions

Type	Name	Description
DRUG	Azithromycin	The patients will receive 500 mg intravenous azithromycin QD for 1 to 2 days. The period of administration of intravenous dosing is judged by investigators according to patient status. Following intravenous administration, the patients will be received the 250 mg oral azithromycin (tablet formulation) QD to complete a total of 7 days therapy.

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-03-30
• Last updated: 2011-11-03
• Results posted: 2011-11-03

Locations

31 sites across 1 country: Japan