Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects With Complicated Intra-Abdominal Infections

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00136201

Collaborator

(none)

200

Enrollment

Locations

Arm

Duration (Months)

18.2

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Abdominal Abscess	Drug: tigecycline	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 armDesc1	Drug: tigecycline

Arm

Intervention/Treatment

Experimental: 1

armDesc1

Drug: tigecycline

Outcome Measures

Primary Outcome Measures

Clinical response for all microbiologically evaluable and microbiologically modified intent-to-treat subjects at the test-of-cure visit []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Guoxuexiang	Chengdu	China	610041
2	Shengyang	Liaoning	China	110001
3	Hangzhou	Zhejiang	China
4	Beijing		China	100044
5	Beijing		China	100730
6	Beijing		China	100853
7	Shanghai		China	200001
8	Shanghai		China	200040
9	Shanghai		China	200092
10	Shanghai		China	200433
11	Wuhan		China	300063