Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.
Phase 3
Completed
- Conditions
- Pelvic Inflammatory Disease
- Interventions
- Registration Number
- NCT00683865
- Lead Sponsor
- Bayer
- Brief Summary
Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease
- Detailed Description
Not available
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)