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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00481962
Recruitment Status : Completed
First Posted : June 4, 2007
Last Update Posted : September 28, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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).

Condition or disease Intervention/treatment Phase
Peritonitis Drug: Tygacil Phase 4

Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units
Study Start Date : February 2006
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tigecycline
U.S. FDA Resources


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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00481962     History of Changes
Other Study ID Numbers: 3074A1-102184
First Posted: June 4, 2007    Key Record Dates
Last Update Posted: September 28, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Peritonitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Tigecycline
Anti-Bacterial Agents
Anti-Infective Agents