Uncomplicated Pelvic Inflammatory Disease; Treatment With Moxifloxacin

Condition(s) targeted: Pelvic Inflammatory Disease

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

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Clinical response 5 to 24 days after the last dose of study medication

Secondary outcome:

Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication

Clinical response at during-treatment visit (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

Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up

Detailed description: 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) MAIDEN study.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Odense C DK-5000, Denmark

Hvidovre 2650, Denmark

Helsinki 00029, Finland

Kotka 48210, Finland

PARIS 75020, France

CRETEIL CEDEX 94010, France

MONTPELLIER 34059, France

BRIVE-LA-GAILLARDE 19100, France

BORDEAUX 33000, France

MURET 31600, France

DOMONT 95330, France

PARIS 75009, France

BEAUMONT 63110, France

CENON 33150, France

ANTONY CEDEX 92166, France

IOANNINA 455 00, Greece

Budapest 1115, Hungary

Budapest H-1085, Hungary

Eger 3301, Hungary

Kecskemet 6000, Hungary

Pavia 27100, Italy

Trieste 34137, Italy

Vilnius LT-04130, Lithuania

Vilnius LT-2021, Lithuania

Vilnius LT-2000, Lithuania

Klaipeda 92288, Lithuania

Krakow 30-501, Poland

Lublin 20-090, Poland

Poznan 61-701, Poland

Bialystok 15-276, Poland

Lodz 93-338, Poland

Moscow 117997, Russian Federation

Moscow 107076, Russian Federation

Moscow 117049, Russian Federation

Lund 221 85, Sweden

Trollhättan 461 85, Sweden

Varberg 432 81, Sweden

Athens, Attica 11528, Greece

Athens, Attica 115 21, Greece

München, Bayern / 280 80336, Germany

Berlin, Berlin / 285 10117, Germany

Bloemfontein, Free State 9300, South Africa

Pretoria, GAUTENG, South Africa

Pretoria, Gauteng 0001, South Africa

Johannesburg, Gauteng 1804, South Africa

Johannesburg, Gauteng 2132, South Africa

London, Greater London SW17 0QT, United Kingdom

Southampton, Hampshire SO14 0YG, United Kingdom

Durban, KwaZulu Natal 4001, South Africa

Rostock, Mecklenburg-Vorpommern / 309 18057, Germany

Leverkusen, Nordrhein-Westfalen / 331 51375, Germany

Essen, Nordrhein-Westfalen / 481 45257, Germany

Wuppertal, Nordrhein-Westfalen / 616 42103, Germany

Grevenbroich, Nordrhein-Westfalen / 623 41515, Germany

Birmingham, West Midlands B4 6DH, United Kingdom

Cape Town, Western Cape, South Africa

Cape Town, Western Cape 7505, South Africa

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Starting date: April 2003
Ending date: October 2004
Last updated: May 23, 2008