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

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00481962

First received: May 31, 2007

Last updated: September 25, 2009

Last verified: September 2009

History of Changes

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 4


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: 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 is now a wholly owned subsidiary of Pfizer:


Enrollment:	180
Study Start Date:	February 2006
Study Completion Date:	December 2008
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Germany

Multiple Cities, Germany

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators


Study Director:	Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:	Trial Manager	For Germany, medinfoDEU@wyeth.com

More Information

No publications provided


Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00481962 History of Changes
Other Study ID Numbers:	3074A1-102184
Study First Received:	May 31, 2007
Last Updated:	September 25, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:


Peritonitis Digestive System Diseases Infection Intraabdominal Infections Peritoneal Diseases

ClinicalTrials.gov processed this record on March 01, 2015

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