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

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

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00683332

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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc Identifier: NCT00683332     History of Changes
Other Study ID Numbers: 3074A1-102235
Study First Received: May 21, 2008
Results First Received: May 2, 2011
Last Updated: June 9, 2011

Keywords provided by Pfizer:
Observational study

Additional relevant MeSH terms:
Communicable Diseases
Intraabdominal Infections
Anti-Bacterial Agents
Anti-Infective Agents processed this record on August 21, 2017