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 | Status | |
|---|---|---|
Locations Investigative Site Odense C, Denmark, DK-5000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ATHENS, Greece, 115 28 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vilnius, Lithuania, LT-2043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bloemfontein, South Africa, 9300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rostock, Germany, 18057 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hvidovre, Denmark, 2650 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kotka, Finland, 48210 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CRETEIL CEDEX, France, 94010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, WC1E 6AU | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Athens, Greece, 115 21 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vilnius, Lithuania, LT-2021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Trollhättan, Sweden, 461 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mamelodi, South Africa, 0122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leverkusen, Germany, 51375 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Helsinki, Finland, 00029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United Kingdom, B4 6DH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1115 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kraków, Poland, 30-501 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 117415 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lund, Sweden, 221 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, H-1085 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Trieste, Italy, 34137 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warsaw, Poland, PL-00-909 | Status Terminated | Contact Us: E-mail: clinical-trials-co[email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 107076 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Grevenbroich, Germany, 41515 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roskilde, Denmark, DK-4000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hämeenlinna, Finland, 13530 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SW10 9NH | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Perugia, Italy, 06126 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONTPELLIER, France, 34059 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site IOANNINA, Greece, 455 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Eger, Hungary, 3300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lublin, Poland, 20-090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 10117 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kecskemet, Hungary, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Poznan, Poland, 60-535 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Varberg, Sweden, 432 81 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cape Town, South Africa, 7925 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Athens, Greece, 115 21 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gyor, Hungary, 9002 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 413 45 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 10249 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONTAUBAN, France, 82000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bristol, United Kingdom, BS2 8HW | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LILLE, France, 59037 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Southampton, United Kingdom, SO14 0YG | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vilnius, Lithuania, LT-2000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 117049 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linköping, Sweden, 581 85 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cape Town, South Africa, 7505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Joensuu, Finland, 80210 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRIVE-LA-GAILLARDE, France, 19100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nottingham, United Kingdom, NG5 1PB | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Klaipeda, Lithuania, LT-5808 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 80337 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site TOULOUSE, France, 31059 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SW17 0QT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bialystok, Poland, 15-276 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Soweto, South Africa, 1804 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site IOANNINA, Greece, 455 00 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lodz, Poland, 93-338 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wuppertal, Germany, 42103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durban, South Africa, 4001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site COLOMBES CEDEX, France, 92701 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MURET, France, 31600 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site DOMONT, France, 95330 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ANTONY CEDEX, France, 92166 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2132 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Essen, Germany, 45257 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 00-416 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NANCY CEDEX, France, 54045 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BORDEAUX, France, 33000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Otwock, Poland, 05-400 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BEAUMONT, France, 63110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CENON, France, 33150 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Denmark | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Greece | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Hungary | Status Terminated | Contact Us: E-mail: [email protected]are.com Phone: Not Available |
Locations Investigative Site Many locations, United Kingdom | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Poland | Status Terminated | 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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