Tigecycline Epsilometer Test (Etest) Study in Taiwan

This study is currently recruiting participants.

Verified by Wyeth, August 2009

First Received: June 18, 2007 Last Updated: August 31, 2009 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00488397

Purpose

In-vitro surveillance study of tigecycline (Tygacil) in Taiwan.

Condition	Phase
Community Acquired Infections	Phase IV

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Tigecycline In-vitro Surveillance Study in Taiwan

Resource links provided by NLM:

Drug Information available for: Tigecycline

U.S. FDA Resources

Further study details as provided by Wyeth:

Biospecimen Retention: None Retained

Biospecimen Description:

Clinical relevant causative isolates

Estimated Enrollment:	6000
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Detailed Description:

To determine the activity of tigecycline against a wide variety of pathogens from both nosocomial and community acquired infections using E-test (Epsilometer test) and micro dilution methods in Taiwan.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

hospital or community acquired infection

Criteria

Inclusion:

Clinically relevant causative isolate (no duplicates) - The isolate must meet the laboratory criteria of "significant pathogen" and be considered the "probable causative agent" of a hospital or community acquired infection.
Sources - All body sites are acceptable clinical sources for isolates to be included in this study (IAI, tracheal secretion/BAL, blood culture, wound smear). However, no more than 10 % of all isolates can come from urine cultures.
Within study group - Only isolates defined by the protocol are to be included.

Exclusion:

Limited isolates from sources - No more than 10 % of all isolates from this study will be derived from urine cultures.
No banked or stored isolates.
No duplicate isolates - Only one isolate per patient is permitted.
Outside study group - Any isolate other than those defined by protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488397

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Taiwan
	Recruiting
Multiple Cities, Taiwan

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Taiwan, medinfo@wyeth.com

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3074A1-102091
Study First Received:	June 18, 2007
Last Updated:	August 31, 2009
ClinicalTrials.gov Identifier:	NCT00488397 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by Wyeth:

Tygacil
(Etest)
Tigecycline
In-Vitro

Study placed in the following topic categories:

Anti-Infective Agents
Anti-Bacterial Agents
Tigecycline
Community-Acquired Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Tigecycline
Therapeutic Uses

Community-Acquired Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2009