CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 76 enrolled
Drug / intervention
Azithromycindrug
Likely dose
Azithromycin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00871494
NCT00871494Phase 3Completed
CompareCT.gov

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

Pfizer·interventional·Posted Mar 30, 2009·Updated Nov 3, 2011

In Brief

A Phase 3 clinical trial evaluating Azithromycin for Pelvic Inflammatory Disease. Completed, enrolled 76 participants across 31 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPelvic Inflammatory Disease
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 30, 2009
Enrollment StartMay 1, 2009
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.3 years ago

Interventions

Azithromycindrug

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.