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Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofloxacin | Drug | Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response 5 to 24 days after the last dose of study medication | 5 to 24 days after the last dose |
| Measure | Description | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre | 2650 | Denmark | ||||
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| Avelox (Moxifloxacin, BAY12-8039) |
| Drug |
Moxifloxacin 400 mg po od for 14 days |
|
| (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) |
| Odense C |
| DK-5000 |
| Denmark |
| Roskilde | DK-4000 | Denmark |
| Hämeenlinna | 13530 | Finland |
| Helsinki | 00029 | Finland |
| Joensuu | 80210 | Finland |
| Kotka | 48210 | Finland |
| Antony | 92166 | France |
| Beaumont | 63110 | France |
| Bordeaux | 33000 | France |
| Brive-la-Gaillarde | 19100 | France |
| Cenon | 33150 | France |
| Colombes | 92701 | France |
| Créteil | 94010 | France |
| Domont | 95330 | France |
| Lille | 59037 | France |
| Montauban | 82000 | France |
| Montpellier | 34059 | France |
| Muret | 31600 | France |
| Nancy | 54045 | France |
| Paris | 75009 | France |
| Paris | 75020 | France |
| Toulouse | 31059 | France |
| München | Bavaria | 80336 | Germany |
| Rostock | Mecklenburg-Vorpommern | 18057 | Germany |
| Essen | North Rhine-Westphalia | 45257 | Germany |
| Grevenbroich | North Rhine-Westphalia | 41515 | Germany |
| Leverkusen | North Rhine-Westphalia | 51375 | Germany |
| Wuppertal | North Rhine-Westphalia | 42103 | Germany |
| Berlin | State of Berlin | 10117 | Germany |
| Berlin | State of Berlin | 10249 | Germany |
| Athens | Attica | 115 21 | Greece |
| Athens | Attica | 11528 | Greece |
| Dourouti-Ioannina | Ioannina | 45500 | Greece |
| Budapest | 1115 | Hungary |
| Budapest | H-1085 | Hungary |
| Eger | 3301 | Hungary |
| Győr | 9024 | Hungary |
| Kecskemét | 6000 | Hungary |
| Pavia | 27100 | Italy |
| Perugia | 06122 | Italy |
| Trieste | 34137 | Italy |
| Klaipėda | 92288 | Lithuania |
| Vilnius | LT-04130 | Lithuania |
| Vilnius | LT-2000 | Lithuania |
| Vilnius | LT-2021 | Lithuania |
| Bialystok | 15-276 | Poland |
| Krakow | 30-501 | Poland |
| Lodz | 93-338 | Poland |
| Lublin | 20-090 | Poland |
| Owock | 05-400 | Poland |
| Poznan | 61-701 | Poland |
| Warsaw | 00-416 | Poland |
| Warsaw | 00-909 | Poland |
| Moscow | 107076 | Russia |
| Moscow | 117049 | Russia |
| Moscow | 117997 | Russia |
| Bloemfontein | Free State | 9300 | South Africa |
| Johannesburg | Gauteng | 1804 | South Africa |
| Johannesburg | Gauteng | 2132 | South Africa |
| Pretoria | Gauteng | 0001 | South Africa |
| Pretoria | Gauteng | South Africa |
| Durban | KwaZulu-Natal | 4001 | South Africa |
| Cape Town | Western Cape | 7505 | South Africa |
| Cape Town | Western Cape | South Africa |
| Gothenburg | 413 45 | Sweden |
| Linköping | 581 85 | Sweden |
| Lund | 221 85 | Sweden |
| Trollhättan | 461 85 | Sweden |
| Varberg | 432 81 | Sweden |
| Bristol | Avon | BS2 8HW | United Kingdom |
| London | Greater London | SW10 9NH | United Kingdom |
| London | Greater London | SW17 0QT | United Kingdom |
| London | Greater London | WC1E 6AU | United Kingdom |
| Southampton | Hampshire | SO14 0YG | United Kingdom |
| Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
| Birmingham | West Midlands | B4 6DH | United Kingdom |
| ID | Term |
|---|---|
| D000292 | Pelvic Inflammatory Disease |
| D034161 | Pelvic Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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