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

NCT ID: NCT00481962

Last Updated: 2009-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Peritonitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Tygacil

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of secondary peritonitis
* Treatment in an ICU
* Patient age \>18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Germany, [email protected]

Locations

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Multiple Cities, , Germany

Site Status

Countries

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Germany

Other Identifiers

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3074A1-102184

Identifier Type: -

Identifier Source: org_study_id

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