Post-Authorization Study Evaluating Safety of Tigecycline - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00827541

Purpose

This is a study to evaluate the safety and efficacy of tigecycline in patients with complicated intra-abdominal infections (cIAI) and complicated skin and soft tissue infections (cSSTI) in the usual health care setting, in order to assess the incidence of adverse events related with tigecycline in these patients. Patients must provide informed consent in order to participate in this study.

Condition
Intra-Abdominal Infection

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Phase IV Pharmacovigilance, Post-Authorization Clinical Trial to Evaluate and Assess the Safety of Tigecycline in the Approved Indications in the Usual Health Care Setting

Resource links provided by NLM:

Drug Information available for: Tigecycline

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Incidence of adverse events and serious adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of adverse events according to the type of infection [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Tissue samples for microbiological testing

Estimated Enrollment:	500
Study Start Date:	August 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Patients hospitalized because of cIAI or cSSTI

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients hospitalized because of cIAI or cSSTI, in the usual health care setting

Criteria

Inclusion criteria:

18 years of age or older at the screening visit
Has cIAI or cSSTI
Are going to or have just been given in the previous 48 hours at least a dose of tigecycline to treat any of the above infections
In the opinion of the investigator, will be able to comply with the requirements of the protocol.

Exclusion criteria:

Known hypersensibility to tigecycline or any of its components
Known significant concurrent medical disease including:
Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception
Use any investigational drug within four weeks of the screening visit
Uncooperative patients or a history of poor compliance

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827541

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Spain
	Recruiting
Valencia, Spain, 46014
Contact: trial manager infomed@wyeth.com

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3074A1-4401
Study First Received:	January 20, 2009
Last Updated:	May 20, 2009
ClinicalTrials.gov Identifier:	NCT00827541 History of Changes
Health Authority:	Spain: Ministry of Health

Keywords provided by Wyeth:

tigecycline

Study placed in the following topic categories:

Anti-Infective Agents
Anti-Bacterial Agents
Tigecycline

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Tigecycline

Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009