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CompletedNCT00136201Updated Jul 7, 2009

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

A Phase 3 interventional study of tigecycline in Abdominal Abscess, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 11 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-07-07.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. \<br />

02

Conditions studied

  • Abdominal Abscess

Keywords

  • Peritonitis
  • Community-Acquired Infections
  • Cross Infection
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Hospitalized male or female subjects over 18 years of age

Exclusion criteria

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants

Study arms

  • Experimental
    1

    armDesc1

    Drug: tigecycline

Interventions

  • Drugtigecycline
05

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. 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

06

Study locations

11 sites
  • Guoxuexiang, Chengdu 610041, China
  • Shengyang, Liaoning 110001, China
  • Hangzhou, Zhejiang, China
  • Beijing, 100044, China
  • Beijing, 100730, China
  • Beijing, 100853, China
  • Shanghai, 200001, China
  • Shanghai, 200040, China
  • Shanghai, 200092, China
  • Shanghai, 200433, China
  • Wuhan, 300063, China
07

References and documents

Publications

  • 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. PubMed 20663130 ↗
  • 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. PubMed 19036670 ↗
08

Registry details

Key details

Study ID
NCT00136201
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Aug 26, 2005
Start date
Nov 2005
Primary completion
Dec 2006
Completion
Dec 2006
Last update
Jul 7, 2009

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager
principal investigator · For China, medinfo@wyeth.com
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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