Post-Marketing Study Of The Safety Of Tygacil (Tigecycline)
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)
2 other identifiers
observational
621
1 country
1
Brief Summary
The purpose of this study is to collect post-marketing information on the safety of Tygacil in Filipino patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 21, 2008
CompletedFirst Posted
Study publicly available on registry
May 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
July 8, 2011
CompletedJuly 8, 2011
June 1, 2011
3.1 years
May 21, 2008
May 2, 2011
June 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Spontaneous Adverse Events
Adverse events were based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participant. In addition to the information obtained from these sources, the participant was asked the following nonspecific question: "How have you been feeling since your last visit?"
30 days post injection up to 3 years
Study Arms (1)
A
Interventions
This is a non-interventional study; patients are administered Tygacil as prescribed by their doctor as per registered indications stated in product label/insert (50 mg by Intravenous Injection).
Eligibility Criteria
All patients who receive one dose of tigecycline
You may qualify if:
- All patients from the study center who received or will receive at least one dose of Tygacil according to the approved product indication.
You may not qualify if:
- Previously discontinued Tygacil therapy due to significant safety concern.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Manila, Philippines
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 21, 2008
First Posted
May 23, 2008
Study Start
April 1, 2007
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
July 8, 2011
Results First Posted
July 8, 2011
Record last verified: 2011-06