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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00683865
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : October 15, 2014
Information provided by (Responsible Party):

Brief Summary:
Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

Condition or disease Intervention/treatment Phase
Pelvic Inflammatory Disease Drug: Ofloxacin Drug: Avelox (Moxifloxacin, BAY12-8039) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 749 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Study Start Date : April 2003
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

Arm Intervention/treatment
Active Comparator: Arm 1 Drug: Ofloxacin
Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days
Experimental: Arm 2 Drug: Avelox (Moxifloxacin, BAY12-8039)
Moxifloxacin 400 mg po od for 14 days

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. Reduction from baseline in pain report at the different assessment visits [ Time Frame: Over the entire trial period (overall) ]
  4. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00683865

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Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00683865     History of Changes
Other Study ID Numbers: 10995
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014

Keywords provided by Bayer:
Antibiotic treatment
Pelvic infection
Interventional study

Additional relevant MeSH terms:
Pelvic Inflammatory Disease
Pelvic Infection
Adnexal Diseases
Genital Diseases, Female
Contraceptive Agents, Female
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Urinary
Renal Agents
Cytochrome P-450 CYP1A2 Inhibitors