Post-Marketing Study Of The Safety Of Tygacil (Tigecycline)
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Complicated Skin and Skin Structure Infections; Complicated Intra-abdominal Infections
Intervention: Tigecycline (Tygacil) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
The purpose of this study is to collect post-marketing information on the safety of Tygacil
in Filipino patients.
Clinical Details
Official title: A Prospective, Observational Study To Monitor Safety In Patients Who Were Administered With Tigecycline (Tygacil) 50 mg By Intravenous Injection (An Observational Study for Safety - Monitored Release)
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Number of Participants With Spontaneous Adverse Events
Detailed description:
Three-thousand or 10% of total number of patients given tigecycline will be included in the
study
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All patients from the study center who received or will receive at least one dose of
Tygacil according to the approved product indication.
Exclusion Criteria:
- Previously discontinued Tygacil therapy due to significant safety concern.
Locations and Contacts
Pfizer Investigational Site, Manila, Philippines
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: April 2007
Last updated: June 9, 2011
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