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

Complicated Intra-abdominal Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683332
• Other study ID #: 3074A1-102235
• Secondary ID: B1811057
• Status: Completed
• Phase: N/A
• First received: May 21, 2008
• Last updated: June 9, 2011
• Start date: April 2007
• Est. completion date: May 2010

Study information

• Verified date: June 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 621
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Complicated Intra-abdominal Infections
• Complicated Skin and Skin Structure Infections
• Infection
• Intraabdominal Infections

Intervention

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).

Locations

Country	Name	City	State
Philippines	Pfizer Investigational Site	Manila

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Spontaneous Adverse Events	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?"	30 days post injection up to 3 years	Yes

External Links

•   To obtain contact information for a study center near you, click here.