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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00683332
First received: May 21, 2008
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to collect post-marketing information on the safety of Tygacil in Filipino patients.


Condition Intervention
Complicated Skin and Skin Structure Infections
Complicated Intra-abdominal Infections
Drug: Tigecycline (Tygacil)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Spontaneous Adverse Events [ Time Frame: 30 days post injection up to 3 years ] [ Designated as safety issue: Yes ]
    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?"


Enrollment: 621
Study Start Date: April 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: 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).

Detailed Description:

Three-thousand or 10% of total number of patients given tigecycline will be included in the study

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients who receive one dose of tigecycline

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683332

Locations
Philippines
Pfizer Investigational Site
Manila, Philippines
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00683332     History of Changes
Other Study ID Numbers: 3074A1-102235, B1811057
Study First Received: May 21, 2008
Results First Received: May 2, 2011
Last Updated: June 9, 2011
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by Pfizer:
Observational study
Tigecycline
infection
skin
abdominal

Additional relevant MeSH terms:
Tigecycline
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014