Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00683865
• Date of registration: 21/05/2008
• Prospective Registration: No
• Primary sponsor: Bayer
• Public title: Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin. MAIDEN
• Scientific title: Prospective, Randomized, Double-blind, Multicenter, Multinational Study Comparing Efficacy and Safety of Moxifloxacin 400 mg po od for 14 Days With Ofloxacin 400 mg po Bid Plus Metronidazole 500 mg po Bid for 14 Days in Patients With Uncomplicated Pelvic Inflammatory Disease (PID)
• Date of first enrolment: April 2003
• Target sample size: 749
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00683865
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Denmark, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Poland, Russian Federation, South Africa, Sweden, United Kingdom

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Pelvic Inflammatory Disease

Intervention(s)

Drug: Ofloxacin

Drug: Avelox (Moxifloxacin, BAY12-8039)

Primary Outcome(s)

Clinical response 5 to 24 days after the last dose of study medication [Time Frame: 5 to 24 days after the last dose]

Secondary Outcome(s)

Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication [Time Frame: 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 [Time Frame: (Day 4-7) and at follow-up 28 to 42 days after last dose]

Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up [Time Frame: Over the entire trial period (overall)]

Reduction from baseline in pain report at the different assessment visits [Time Frame: Over the entire trial period (overall)]

Secondary ID(s)

10995

Source(s) of Monetary Support

Please refer to primary and secondary sponsors