Tigecycline In-Vitro Surveillance Study In Taiwan | NCT00488397 | Trialant
CompletedObservationalUpdated Mar 22, 2011
Tigecycline In-Vitro Surveillance Study In Taiwan
Tigecycline In-Vitro Surveillance Study In Taiwan
ClinicalTrials.gov ID
NCT00488397
Lead Sponsor
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Overall Status
Completed
Study Type
Observational
Enrollment
7,902Actual
Last Update Posted
Mar 22, 2011Estimated
Start Date
Aug 2006
Primary Completion Date
Feb 2011Actual
Completion Date
Feb 2011Actual
Official Title
Tigecycline In-Vitro Surveillance Study In Taiwan
Brief Summary
In-vitro surveillance study of tigecycline (Tygacil) in Taiwan.
Community Acquired Infections
In-vitro testing
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Observational Model
Cohort
Time Perspective
Prospective
No central contacts
There are no central contacts for this study.
Pfizer Investigational Site
Taipei, Taiwan 100, China
Lead Sponsor
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY