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

October 12, 2014 updated by: Bayer

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)

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

749

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
      • Odense C, Denmark, DK-5000
      • Roskilde, Denmark, DK-4000
  • Finland
      • Helsinki, Finland, 00029
      • Hämeenlinna, Finland, 13530
      • Joensuu, Finland, 80210
      • Kotka, Finland, 48210
  • France
      • Antony Cedex, France, 92166
      • Beaumont, France, 63110
      • Bordeaux, France, 33000
      • Brive-la-gaillarde, France, 19100
      • Cenon, France, 33150
      • Colombes Cedex, France, 92701
      • Creteil Cedex, France, 94010
      • Domont, France, 95330
      • Lille, France, 59037
      • Montauban, France, 82000
      • Montpellier, France, 34059
      • Muret, France, 31600
      • Nancy Cedex, France, 54045
      • Paris, France, 75009
      • Paris, France, 75020
      • Toulouse, France, 31059
  • Germany
      • Berlin, Germany, 10117
      • Berlin, Germany, 10249
    • Bayern
      • München, Bayern, Germany, 80336
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18057
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45257
      • Grevenbroich, Nordrhein-Westfalen, Germany, 41515
      • Leverkusen, Nordrhein-Westfalen, Germany, 51375
      • Wuppertal, Nordrhein-Westfalen, Germany, 42103
  • Greece
    • Attica
      • Athens, Attica, Greece, 115 21
      • Athens, Attica, Greece, 11528
    • Ioannina
      • Dourouti-Ioannina, Ioannina, Greece, 45500
  • Hungary
      • Budapest, Hungary, 1115
      • Budapest, Hungary, H-1085
      • Eger, Hungary, 3301
      • Györ, Hungary, 9024
      • Kecskemet, Hungary, 6000
  • Italy
      • Pavia, Italy, 27100
      • Perugia, Italy, 06122
      • Trieste, Italy, 34137
  • Lithuania
      • Klaipeda, Lithuania, 92288
      • Vilnius, Lithuania, LT-04130
      • Vilnius, Lithuania, LT-2021
      • Vilnius, Lithuania, LT-2000
  • Poland
      • Bialystok, Poland, 15-276
      • Krakow, Poland, 30-501
      • Lodz, Poland, 93-338
      • Lublin, Poland, 20-090
      • Owock, Poland, 05-400
      • Poznan, Poland, 61-701
      • Warszawa, Poland, 00-909
      • Warszawa, Poland, 00-416
  • Russian Federation
      • Moscow, Russian Federation, 107076
      • Moscow, Russian Federation, 117049
      • Moscow, Russian Federation, 117997
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa, 9300
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2132
      • Johannesburg, Gauteng, South Africa, 1804
      • Pretoria, Gauteng, South Africa
      • Pretoria, Gauteng, South Africa, 0001
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa, 4001
    • Western Cape
      • Cape Town, Western Cape, South Africa
      • Cape Town, Western Cape, South Africa, 7505
  • Sweden
      • Göteborg, Sweden, 413 45
      • Linköping, Sweden, 581 85
      • Lund, Sweden, 221 85
      • Trollhättan, Sweden, 461 85
      • Varberg, Sweden, 432 81
  • United Kingdom
    • Avon
      • Bristol, Avon, United Kingdom, BS2 8HW
    • Greater London
      • London, Greater London, United Kingdom, SW10 9NH
      • London, Greater London, United Kingdom, SW17 0QT
      • London, Greater London, United Kingdom, WC1E 6AU
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO14 0YG
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B4 6DH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
(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
Time Frame: Over the entire trial period (overall)
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
Time Frame: Over the entire trial period (overall)
Over the entire trial period (overall)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (ACTUAL)

October 1, 2004

Study Completion (ACTUAL)

October 1, 2004

Study Registration Dates

First Submitted

May 21, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (ESTIMATE)

May 26, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 12, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10995 (Registry Identifier: DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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