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Clinical Trials/NCT00488397
NCT00488397CompletedNot Applicable

Tigecycline In-Vitro Surveillance Study In Taiwan

Wyeth is now a wholly owned subsidiary of Pfizer1 site in 1 country7,902 target enrollmentStarted: August 2006Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
7,902
Locations
1
Primary Endpoint
Prior to 2009: Susceptibility data of minimum inhibitory concentration (MIC), MIC50, MIC90by pathogen, tested by E-test.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

In-vitro surveillance study of tigecycline (Tygacil) in Taiwan.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Clinically relevant causative isolate (no duplicates) - The isolate must meet the laboratory criteria of "significant pathogen" and be considered the "probable causative agent" of a hospital or community acquired infection.
  • •Sources - All body sites are acceptable clinical sources for isolates to be included in this study (Intra-abdominal infection, tracheal secretion/bronchoalveolar lavage, blood culture, wound smear). However, no more than 10 % of all isolates can come from urine cultures.
  • •Within study group - Only isolates defined by the protocol are to be included.

Exclusion Criteria

  • •Limited isolates from sources - No more than 10 % of all isolates from this study will be derived from urine cultures.
  • •No banked or stored isolates.
  • •No duplicate isolates - Only one isolate per patient is permitted.
  • •Outside study group - Any isolate other than those defined by protocol.

Outcomes

Primary Outcomes

Prior to 2009: Susceptibility data of minimum inhibitory concentration (MIC), MIC50, MIC90by pathogen, tested by E-test.

Time Frame: in vitro study therefore not applicable

Post-2009: Susceptibility data of MIC, MIC50, MIC90 by pathogen, tested by micro-dilution method

Time Frame: in vitro study therefore not applicable

Secondary Outcomes

  • Prior to 2009: 1. Susceptibility data of minimum inhibitory concentration (MIC), MIC50, MIC90 by pathogen, tested by micro-dilution method 2. Susceptibility data of inhibition zone diameter(mm) by pathogen, tested by paper disc.(in vitro study therefore not applicable)
  • Post-2009: Susceptibility data of inhibition zone diameter (mm) by pathogen, tested by paper disc.(in vitro study therefore not applicable)

Investigators

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor Class
Industry

Study Sites (1)

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Tigecycline In-Vitro Surveillance Study In... | Clinical Trial