Post-Marketing Study of the Safety of Tygacil (Tigecycline)

This study is currently recruiting participants.

Verified by Wyeth, May 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00683332

Purpose

To collect post-marketing information on the safety of Tygacil in Filipino patients

Condition	Intervention
Infection	Drug: Tigecycline (Tygacil)

Drug Information available for: Tigecycline

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	A Prospective, Observational Study to Monitor Safety in Patients Who Were Administered With Tigecycline (Tygacil) 50 mg by Intravenous Injection

Further study details as provided by Wyeth:

Primary Outcome Measures:

Spontaneous Adverse Events will be collected until 30 days after each injection [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1	Drug: Tigecycline (Tygacil)

Eligibility

Study Population

Primary Care

Criteria

Inclusion Criteria:

All patients from the study center who received or will receive at least one dose of Tygacil according to the approved product indication and who have not previously discontinued therapy due to safety concerns.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683332

Contacts

Contact: Trial Manager

Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3074A1-102235
Study First Received:	May 21, 2008
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00683332
Health Authority:	Philippines: Bureau of Food and Drugs

Study placed in the following topic categories:

Tigecycline

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009