Trial Condition(s):
Pelvic Inflammatory Disease
Uncomplicated pelvic inflammatory disease. Treatment with Moxifloxacin. (MAIDEN)
Bayer Identifier:
10995
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Odense C, Denmark, DK-5000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ATHENS, Greece, 115 28 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vilnius, Lithuania, LT-2043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bloemfontein, South Africa, 9300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rostock, Germany, 18057 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hvidovre, Denmark, 2650 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kotka, Finland, 48210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CRETEIL CEDEX, France, 94010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, WC1E 6AU | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Athens, Greece, 115 21 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vilnius, Lithuania, LT-2021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Trollhättan, Sweden, 461 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mamelodi, South Africa, 0122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leverkusen, Germany, 51375 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Helsinki, Finland, 00029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United Kingdom, B4 6DH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kraków, Poland, 30-501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 117415 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lund, Sweden, 221 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, H-1085 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Trieste, Italy, 34137 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warsaw, Poland, PL-00-909 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 107076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Grevenbroich, Germany, 41515 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roskilde, Denmark, DK-4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hämeenlinna, Finland, 13530 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SW10 9NH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Perugia, Italy, 06126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONTPELLIER, France, 34059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site IOANNINA, Greece, 455 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Eger, Hungary, 3300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lublin, Poland, 20-090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 10117 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kecskemet, Hungary, 6000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Poznan, Poland, 60-535 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Varberg, Sweden, 432 81 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cape Town, South Africa, 7925 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Athens, Greece, 115 21 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gyor, Hungary, 9002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 413 45 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 10249 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONTAUBAN, France, 82000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bristol, United Kingdom, BS2 8HW | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LILLE, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Southampton, United Kingdom, SO14 0YG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vilnius, Lithuania, LT-2000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 117049 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linköping, Sweden, 581 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cape Town, South Africa, 7505 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Joensuu, Finland, 80210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRIVE-LA-GAILLARDE, France, 19100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nottingham, United Kingdom, NG5 1PB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Klaipeda, Lithuania, LT-5808 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 80337 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site TOULOUSE, France, 31059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SW17 0QT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bialystok, Poland, 15-276 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Soweto, South Africa, 1804 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site IOANNINA, Greece, 455 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lodz, Poland, 93-338 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wuppertal, Germany, 42103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durban, South Africa, 4001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site COLOMBES CEDEX, France, 92701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MURET, France, 31600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site DOMONT, France, 95330 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ANTONY CEDEX, France, 92166 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Essen, Germany, 45257 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 00-416 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NANCY CEDEX, France, 54045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BORDEAUX, France, 33000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Otwock, Poland, 05-400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BEAUMONT, France, 63110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CENON, France, 33150 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Denmark | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Greece | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Hungary | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, United Kingdom | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Poland | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Clinical response 5 to 24 days after the last dose of study medicationTimeframe: 5 to 24 days after the last dose
Secondary Outcome
- Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medicationTimeframe: 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 doseTimeframe: (Day 4-7) and at follow-up 28 to 42 days after last dose
- Reduction from baseline in pain report at the different assessment visitsTimeframe: 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-upTimeframe: Over the entire trial period (overall)
Additional Information
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