Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.

Phase 3

Completed

• Conditions: Pelvic Inflammatory Disease
• Interventions: Drug: Avelox (Moxifloxacin, BAY12-8039); Drug: Ofloxacin

• Registration Number: NCT00683865
• Lead Sponsor: Bayer

Brief Summary

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2004-10
• Study Completion: 2004-10
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-23
• Study First Posted: 2008-05-26
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-12
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 749

Inclusion Criteria

• Diagnosis of PID based on: pelvic discomfort- Direct lower abdominal tenderness;
• Adnexal tenderness on bimanual vaginal examination,
• Temperature > 38.0°C; - Elevated C-reactive protein value (CRP);
• Signed PIC/IC

Exclusion Criteria

• Pregnancy
• Abnormal lab values

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Avelox (Moxifloxacin, BAY12-8039)	-
Arm 1	Ofloxacin	-

Primary Outcome Measures

Name	Time	Method
Clinical response 5 to 24 days after the last dose of study medication	5 to 24 days after the last dose

Secondary Outcome Measures

Name	Time	Method
Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication	visit 28 to 42 days after last dose
Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose	(Day 4-7) and at follow-up 28 to 42 days after last dose
Reduction from baseline in pain report at the different assessment visits	Over the entire trial period (overall)
Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up	Over the entire trial period (overall)