Abdominal Abscess Clinical Trial
Official title:
A Multicenter, Randomized, Open-Label Comparison of the Safety and Efficacy of Tigecycline> vs Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Chinese Subjects
The primary objective of this study is to compare the safety and efficacy of an experimental antibiotic to a marketed antibiotic in the treatment of Chinese subjects with complicated intra-abdominal infections. <br />
Status | Completed |
Enrollment | 200 |
Est. completion date | December 2006 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: · Hospitalized male or female subjects over 18 years of age Exclusion Criteria: · Subjects with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up visits could be completed. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical response for all microbiologically evaluable and microbiologically modified intent-to-treat subjects at the test-of-cure visit | |||
Secondary | Microbiological response at the subject and pathogen level and evaluation of microbiological data, such as decreased susceptibility, response rates by baseline isolate and minimal inhibitory concentration (MIC) values and susceptibility data by isolate |
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