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Completed

NCT Number: NCT00683865

Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

Completed

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Key information

Conditions

Pelvic Inflammatory Disease Adnexal Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Pelvic Infection Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hvidovre, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ofloxacin

Drug

Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days

Avelox (Moxifloxacin, BAY12-8039)

Drug

Moxifloxacin 400 mg po od for 14 days

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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)

Acronym: MAIDEN

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
May 26, 2008
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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