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

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. Identifier: NCT00683332
Recruitment Status : Completed
First Posted : May 23, 2008
Results First Posted : July 8, 2011
Last Update Posted : July 8, 2011
Information provided by:

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

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

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

Study Type : Observational
Actual Enrollment : 621 participants
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)
Study Start Date : April 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Tigecycline

Group/Cohort Intervention/treatment
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).

Primary Outcome Measures :
  1. 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?"

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who receive one dose of tigecycline

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.

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 identifier (NCT number): NCT00683332

Pfizer Investigational Site
Manila, Philippines
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc Identifier: NCT00683332     History of Changes
Other Study ID Numbers: 3074A1-102235
First Posted: May 23, 2008    Key Record Dates
Results First Posted: July 8, 2011
Last Update Posted: July 8, 2011
Last Verified: June 2011

Keywords provided by Pfizer:
Observational study

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