Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.

NCT00683865 | Completed Phase 3

• 1 other identifier: 10995
• Study Type: interventional
• Target: 749
• Locations: 13 countries
• Sites: 77

Brief Summary

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

Conditions

Pelvic Inflammatory Disease

Keywords

Antibiotic treatment; Pelvic infection; Interventional study; Female

Outcome Measures

Primary Outcomes (1)

• Clinical response 5 to 24 days after the last dose of study medication

  5 to 24 days after the last dose

Secondary Outcomes (4)

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

  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

  (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

  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

  Over the entire trial period (overall)

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Drug: Ofloxacin

Arm 2

EXPERIMENTAL

Drug: Avelox (Moxifloxacin, BAY12-8039)

Interventions

Ofloxacin DRUG

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

Arm 1

Avelox (Moxifloxacin, BAY12-8039) DRUG

Moxifloxacin 400 mg po od for 14 days

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Abnormal lab values

Sponsors & Collaborators

• Bayer: lead

Study Sites (77)

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Hvidovre, 2650, Denmark

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Odense C, DK-5000, Denmark

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Roskilde, DK-4000, Denmark

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Hämeenlinna, 13530, Finland

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Helsinki, 00029, Finland

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Joensuu, 80210, Finland

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Kotka, 48210, Finland

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Antony, 92166, France

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Beaumont, 63110, France

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Bordeaux, 33000, France

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Brive-la-Gaillarde, 19100, France

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Cenon, 33150, France

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Colombes, 92701, France

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Créteil, 94010, France

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Domont, 95330, France

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Lille, 59037, France

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Montauban, 82000, France

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Montpellier, 34059, France

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Muret, 31600, France

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Nancy, 54045, France

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Paris, 75009, France

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Paris, 75020, France

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Toulouse, 31059, France

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München, Bavaria, 80336, Germany

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Rostock, Mecklenburg-Vorpommern, 18057, Germany

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Essen, North Rhine-Westphalia, 45257, Germany

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Grevenbroich, North Rhine-Westphalia, 41515, Germany

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Leverkusen, North Rhine-Westphalia, 51375, Germany

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Wuppertal, North Rhine-Westphalia, 42103, Germany

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Berlin, State of Berlin, 10117, Germany

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Berlin, State of Berlin, 10249, Germany

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Athens, Attica, 115 21, Greece

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Athens, Attica, 11528, Greece

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Dourouti-Ioannina, Ioannina, 45500, Greece

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Budapest, 1115, Hungary

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Budapest, H-1085, Hungary

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Eger, 3301, Hungary

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Győr, 9024, Hungary

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Kecskemét, 6000, Hungary

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Pavia, 27100, Italy

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Perugia, 06122, Italy

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Trieste, 34137, Italy

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Klaipėda, 92288, Lithuania

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Vilnius, LT-04130, Lithuania

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Vilnius, LT-2000, Lithuania

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Vilnius, LT-2021, Lithuania

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Bialystok, 15-276, Poland

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Krakow, 30-501, Poland

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Lodz, 93-338, Poland

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Lublin, 20-090, Poland

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Owock, 05-400, Poland

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Poznan, 61-701, Poland

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Warsaw, 00-416, Poland

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Warsaw, 00-909, Poland

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Moscow, 107076, Russia

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Moscow, 117049, Russia

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Moscow, 117997, Russia

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Bloemfontein, Free State, 9300, South Africa

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Johannesburg, Gauteng, 1804, South Africa

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Johannesburg, Gauteng, 2132, South Africa

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Pretoria, Gauteng, 0001, South Africa

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Pretoria, Gauteng, South Africa

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Durban, KwaZulu-Natal, 4001, South Africa

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Cape Town, Western Cape, 7505, South Africa

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Cape Town, Western Cape, South Africa

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Gothenburg, 413 45, Sweden

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Linköping, 581 85, Sweden

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Lund, 221 85, Sweden

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Trollhättan, 461 85, Sweden

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Varberg, 432 81, Sweden

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Bristol, Avon, BS2 8HW, United Kingdom

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London, Greater London, SW10 9NH, United Kingdom

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London, Greater London, SW17 0QT, United Kingdom

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London, Greater London, WC1E 6AU, United Kingdom

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Southampton, Hampshire, SO14 0YG, United Kingdom

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Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

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Birmingham, West Midlands, B4 6DH, United Kingdom

Location

MeSH Terms

Conditions

Pelvic Inflammatory Disease; Pelvic Infection

Interventions

Ofloxacin; Moxifloxacin

Condition Hierarchy (Ancestors)

Infections; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 26, 2008
• Study Start: April 1, 2003
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

FR (16); GR (3); LI (4); FI (4); RU (3); ZA (8); DE (8); SE (5); DK (3); GB (7); PL (8); HU (5); IT (3)