Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin. (MAIDEN)

Bayer

Status and phase: Completed; Phase 3

Conditions: Pelvic Inflammatory Disease

Treatments: Drug: Avelox (Moxifloxacin, BAY12-8039); Drug: Ofloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00683865

10995 (Registry Identifier)

Details and patient eligibility

About

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

Enrollment: 749 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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749 participants in 2 patient groups

Arm 1

Active Comparator group

Treatment:

Drug: Ofloxacin

Arm 2

Experimental group

Treatment:

Drug: Avelox (Moxifloxacin, BAY12-8039)