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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00683332
First Posted: May 23, 2008
Last Update Posted: July 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00683332     History of Changes
Other Study ID Numbers: 3074A1-102235
B1811057
First Submitted: May 21, 2008
First Posted: May 23, 2008
Results First Submitted: May 2, 2011
Results First Posted: July 8, 2011
Last Update Posted: July 8, 2011
Last Verified: June 2011

Keywords provided by Pfizer:
Observational study
Tigecycline
infection
skin
abdominal

Additional relevant MeSH terms:
Infection
Communicable Diseases
Intraabdominal Infections
Tigecycline
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents