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The purpose of this study is to assess the safety and efficacy of intravenous administration Moxifloxacin (BAY 12-8039) compared to intravenous ceftriaxone and metronidazole for the treatment of patients with complicated intra abdominal infections. In view of the fact that intra abdominal infections are typically polymicrobial and are often treated empirically, the selected antibacterial agent must cover the likely spectrum of bacterial pathogens. Combination antibiotics therapy has been widely used with great success.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 2 | Active Comparator |
| |
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelox (Moxifloxacin, BAY12-8039) | Drug | Moxifloxacin 400 mg every 24 h |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response | After 10-14 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and bacteriological response | During 3-5days of treatment | |
| Bacteriological and radiological response | After 10-14 days of treatment | |
| Clinical response at the TOC visit in patients with bacteriological proven intra abdominal infection |
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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 |
|---|---|---|---|---|---|---|
| Nanjing | Jiangsu | China | ||||
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| Ceftriaxone + Metronidazole |
| Drug |
Ceftriaxone 2 g every 24 h and Metronidazole 500 mg every 12 h |
|
| After 10-14 days of treatment |
| Mortality attributable to intra abdominal infection | 13-28 days |
| Chengdu |
| Sichuan |
| 610041 |
| China |
| Hangzhou | Zhejiang | 310003 | China |
| Beijing | 100044 | China |
| Beijing | 100050 | China |
| Beijing | 100730 | China |
| Beijing | China |
| Shanghai | 200032 | China |
| Shanghai | 200127 | China |
| Shanghai | 200233 | China |
| Shanghai | China |
| Tianjin | 300000 | China |
| Hong Kong | Hong Kong | Hong Kong |
| Shatin | New Territories | Hong Kong |
| Bandung | West Java | 40161 | Indonesia |
| Kuching | Sarawak | 93400 | Malaysia |
| Terengganu | 20400 | Malaysia |
| Uijeongbu-si | Kyonggi-do | 480-130 | South Korea |
| Incheon | 405-760 | South Korea |
| Seoul | 137-701 | South Korea |
| Seoul | 150-713 | South Korea |
| Seoul | 420-717 | South Korea |
| Tainan | Tainan | 70428 | Taiwan |
| Kaoshiung | 813 | Taiwan |
| Taipei | Taiwan |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| D002443 | Ceftriaxone |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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