check_circleStudy Completed
Infection, intra-abdominal
Bayer Identifier:
11647
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Dragon study (the safety and efficacy for treatment of patients with complicated intra abdominal infections)
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
364Trial Dates
October 2005 - January 2007Phase
Phase 3Could I Receive a placebo
NoProducts
Avelox (Moxifloxacin hydrochloride, BAY12-8039)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Beijing, 100730, China | |
Completed | Beijing, 100730, China | |
Completed | Beijing, 100044, China | |
Completed | Shanghai, 200233, China | |
Completed | Shanghai, 200032, China | |
Completed | Hangzhou, 310003, China | |
Completed | Shanghai, 200127, China | |
Withdrawn | Tianjin, 300000, China | |
Withdrawn | Shanghai, 200127, China | |
Completed | Beijing, 100050, China | |
Completed | Seoul, 150-713, Korea, Republic Of | |
Completed | Uijeongbu-si, 480-130, Korea, Republic Of | |
Completed | Incheon, 21565, Korea, Republic Of | |
Withdrawn | Kaoshiung, 81346, Taiwan | |
Completed | Shanghai, 200080, China | |
Completed | Shanghai, 200092, China | |
Completed | Chengdu, 610041, China | |
Completed | Nanjing, China | |
Withdrawn | Tianjin, 300000, China | |
Completed | Bandung, 40161, Indonesia | |
Completed | Seoul, 110-744, Korea, Republic Of | |
Completed | Bucheon-si, 420-717, Korea, Republic Of | |
Withdrawn | Tainan, Taiwan | |
Completed | Hong Kong, Hong Kong | |
Completed | Sarawak, 93400, Malaysia | |
Withdrawn | Terengganu, 20400, Malaysia | |
Withdrawn | Taipei, Taiwan | |
Completed | Hong Kong, Hong Kong |
Primary Outcome
- Clinical Responsedate_rangeTime Frame:After 10-14 days of treatmentenhanced_encryptionyesSafety Issue:
Secondary Outcome
- Clinical and bacteriological responsedate_rangeTime Frame:During 3-5days of treatmentenhanced_encryptionyesSafety Issue:
- Bacteriological and radiological responsedate_rangeTime Frame:After 10-14 days of treatmentenhanced_encryptionyesSafety Issue:
- Clinical response at the TOC visit in patients with bacteriological proven intra abdominal infectiondate_rangeTime Frame:After 10-14 days of treatmentenhanced_encryptionyesSafety Issue:
- Mortality attributable to intra abdominal infectiondate_rangeTime Frame:13-28 daysenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2