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

NCT ID: NCT00136201

Last Updated: 2009-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-12-31

Brief Summary

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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 /\>

Detailed Description

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Conditions

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Abdominal Abscess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

armDesc1

Group Type EXPERIMENTAL

tigecycline

Intervention Type DRUG

Interventions

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tigecycline

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For China, [email protected]

Locations

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Guoxuexiang, Chengdu, China

Site Status

Shengyang, Liaoning, China

Site Status

Hangzhou, Zhejiang, China

Site Status

Beijing, , China

Site Status

Beijing, , China

Site Status

Beijing, , China

Site Status

Shanghai, , China

Site Status

Shanghai, , China

Site Status

Shanghai, , China

Site Status

Shanghai, , China

Site Status

Wuhan, , China

Site Status

Countries

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China

References

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Fomin P, Koalov S, Cooper A, Babinchak T, Dartois N, De Vane N, Castaing N, Tellado J; 301 And 306 Study Groups. The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections - the European experience. J Chemother. 2008 Oct;20 Suppl 1:12-9. doi: 10.1179/joc.2008.20.Supplement-1.12.

Reference Type DERIVED
PMID: 19036670 (View on PubMed)

Chen Z, Wu J, Zhang Y, Wei J, Leng X, Bi J, Li R, Yan L, Quan Z, Chen X, Yu Y, Wu Z, Liu D, Ma X, Maroko R, Cooper A. Efficacy and safety of tigecycline monotherapy vs. imipenem/cilastatin in Chinese patients with complicated intra-abdominal infections: a randomized controlled trial. BMC Infect Dis. 2010 Jul 21;10:217. doi: 10.1186/1471-2334-10-217.

Reference Type DERIVED
PMID: 20663130 (View on PubMed)

Other Identifiers

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3074A1-316

Identifier Type: -

Identifier Source: org_study_id

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