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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
364
Moxifloxacin 400 mg every 24 h
Ceftriaxone 2 g every 24 h and Metronidazole 500 mg every 12 h
Unnamed facility
Nanjing, Jiangsu, China
Unnamed facility
Chengdu, Sichuan, China
Clinical Response
Time frame: After 10-14 days of treatment
Clinical and bacteriological response
Time frame: During 3-5days of treatment
Bacteriological and radiological response
Time frame: After 10-14 days of treatment
Clinical response at the TOC visit in patients with bacteriological proven intra abdominal infection
Time frame: After 10-14 days of treatment
Mortality attributable to intra abdominal infection
Time frame: 13-28 days
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Unnamed facility
Hangzhou, Zhejiang, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Shanghai, China
Unnamed facility
Shanghai, China
Unnamed facility
Shanghai, China
...and 15 more locations