Not Signed In -
Abscess |
|
|
Clinical Trial: Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects with Complicated Intra-Abdominal Infections
This study is not yet open for patient recruitment.
Verified by Wyeth August 2005
|
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Abdominal Abscess Peritonitis | Drug: Tigecycline | Phase III |
MedlinePlus related topics: Abscesses; Digestive Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
Further Study Details:
Primary Outcomes: Clinical response for all microbiologically evaluable and microbiological modified intent-to-treat subjects at the test-of-cure visit.
Secondary Outcomes: Microbiological response at the subject and pathogen level & evaluation of microbiological data, such as decreased susceptibility, response rates by baseline isolate and MIC values and susceptibility data by isolate
Expected Total Enrollment: 200
Secondary Outcomes: Microbiological response at the subject and pathogen level & evaluation of microbiological data, such as decreased susceptibility, response rates by baseline isolate and MIC values and susceptibility data by isolate
Expected Total Enrollment: 200
Study start: September 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Hospitalized male or female subjects over 18 years of age
Exclusion Criteria:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00136201
Trial . Manager medinfo@wyeth.com
China
Shanghai, 200040, China
see Central Contact
Shanghai, 200433, China
see Central Contact
Beijing, 100044, China
see Central Contact
Beijing, 100730, China
see Central Contact
Beijing, 100730, China
see Central Contact
Shanghai, 200001, China
see Central Contact
WUHAN, 300063, China
see Central Contact
China, Chengdu
Guoxuexiang, Chengdu, 610041, China
see Central Contact
China, LiaoNing
Shengyang, LiaoNing, 110001, China
see Central Contact
China, Zhejiang
Hangzhou, Zhejiang, China
see Central Contact
Study chairs or principal investigators
Medical Monitor, Study Director, Wyeth Research
More Information
Study ID Numbers: 3074A1-316
Last Updated: August 25, 2005
Record first received: August 25, 2005
ClinicalTrials.gov Identifier: NCT00136201
Health Authority: China: State Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30
Last Updated: August 25, 2005
Record first received: August 25, 2005
ClinicalTrials.gov Identifier: NCT00136201
Health Authority: China: State Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30
email this page
print this page
bookmark this page
feedback on this page
