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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:
    Drug: Tygacil
    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

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
Peritoneal Diseases
Digestive System Diseases
Tigecycline
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013