Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units (ICUs)

This study is currently recruiting participants.

Verified by Wyeth, November 2008

First Received: May 31, 2007 Last Updated: November 6, 2008 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00481962

Purpose

The main goals of the study are: Assessment of Tygacil's cost-effectiveness; Process cost analysis from a hospital perspective (including length of stay, treatment costs, side effect management costs, costs of monitoring, costs of diagnostic procedures, cost of care (TISS 10 score etc.); Efficacy of Tygacil under usual care conditions (cure rate).

Condition	Intervention	Phase
Peritonitis	Drug: Tygacil	Phase IV

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units

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:

Estimated Enrollment:	100
Study Start Date:	February 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Initial dose of 100mg followed by 50mg every 12 hours for 5 to 14 days

Eligibility

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

Study Population

primary care clinical

Criteria

Inclusion Criteria:

Diagnosis of secondary peritonitis
Treatment in an ICU
Patient age >18 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481962

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Germany
	Recruiting
Multiple Cities, Germany

Sponsors and Collaborators

Wyeth

Investigators

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

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3074A1-102184
Study First Received:	May 31, 2007
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00481962 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Anti-Infective Agents
Anti-Bacterial Agents
Digestive System Diseases
Tigecycline

Peritonitis
Peritoneal Diseases
Neoplasm Metastasis

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Digestive System Diseases
Tigecycline

Therapeutic Uses
Peritonitis
Peritoneal Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009