NCT00136201

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. \<br /\>

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 7, 2009

Status Verified

July 1, 2009

Enrollment Period

1.1 years

First QC Date

August 25, 2005

Last Update Submit

July 6, 2009

Conditions

Abdominal Abscess

Keywords

PeritonitisCommunity-Acquired InfectionsCross Infection

Outcome Measures

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

Study Arms (1)

1

EXPERIMENTAL

armDesc1

Drug: tigecycline

Interventions

tigecyclineDRUG
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • · Hospitalized male or female subjects over 18 years of age

You may not qualify if:

  • · 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Guoxuexiang, Chengdu, 610041, China

Location

Unknown Facility

Shengyang, Liaoning, 110001, China

Location

Unknown Facility

Hangzhou, Zhejiang, China

Location

Unknown Facility

Beijing, 100044, China

Location

Unknown Facility

Beijing, 100730, China

Location

Unknown Facility

Beijing, 100853, China

Location

Unknown Facility

Shanghai, 200001, China

Location

Unknown Facility

Shanghai, 200040, China

Location

Unknown Facility

Shanghai, 200092, China

Location

Unknown Facility

Shanghai, 200433, China

Location

Unknown Facility

Wuhan, 300063, China

Location

Related Publications (2)

  • 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.

    PMID: 20663130DERIVED

  • 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.

    PMID: 19036670DERIVED

MeSH Terms

Conditions

Abdominal AbscessPeritonitisCommunity-Acquired InfectionsCross Infection

Interventions

Tigecycline

Condition Hierarchy (Ancestors)

AbscessSuppurationInfectionsIntraabdominal InfectionsPeritoneal DiseasesDigestive System DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For China, medinfo@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 26, 2005

Study Start

November 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

July 7, 2009

Record last verified: 2009-07

Locations

CN(11)