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Post-Marketing Study Of The Safety Of Tygacil (Tigecycline)

Last updated on November 12, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Manila, , Philippines
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Previously discontinued Tygacil therapy due to significant safety concern.

NCT00683332
Pfizer
Completed
Post-Marketing Study Of The Safety Of Tygacil (Tigecycline)

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[email protected]

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cIAIs Complicated Intra-Abdominal Infections
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18+
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Descriptive Information
Brief TitlePost-Marketing Study Of The Safety Of Tygacil (Tigecycline)
Official TitleA 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)
Brief SummaryThe purpose of this study is to collect post-marketing information on the safety of Tygacil in Filipino patients.
Detailed DescriptionThree-thousand or 10% of total number of patients given tigecycline will be included in the study
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationAll patients who receive one dose of tigecycline
Condition
  • Complicated Skin and Skin Structure Infections
  • Complicated Intra-abdominal Infections
InterventionDrug: Tigecycline (Tygacil)
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).
Study Groups/CohortsA
Intervention: Drug: Tigecycline (Tygacil)
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: November 10, 2010)
621
Original Estimated Enrollment
 (submitted: May 22, 2008)
500
Actual Study Completion DateMay 2010
Actual Primary Completion DateMay 2010   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesPhilippines
Removed Location CountriesUnited States
 
Administrative Information
NCT NumberNCT00683332
Other Study ID Numbers3074A1-102235
B1811057
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2011

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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