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NCT00481962 Clinical Trial

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

Peritonitis Clinical Trial

Official title:
Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00481962
Other study ID # 3074A1-102184
Secondary ID
Status Completed
Phase Phase 4
First received May 31, 2007
Last updated September 25, 2009
Start date February 2006
Est. completion date December 2008

Study information
Verified date September 2009
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of secondary peritonitis

- Treatment in an ICU

- Patient age >18 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Germany, 

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