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

Completed

• Conditions: Complicated Skin and Skin Structure Infections; Complicated Intra-abdominal Infections
• Interventions: Drug: Tigecycline (Tygacil)

• Registration Number: NCT00683332
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-22
• Study First Posted: 2008-05-23
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2011-05-02
• Status Verified: 2011-06
• Results First Submitted QC: 2011-06-09
• Last Update Submitted: 2011-06-09
• Results First Posted: 2011-07-08
• Last Update Posted: 2011-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 621

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Tigecycline (Tygacil)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Spontaneous Adverse Events	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?"

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇭 Manila, Philippines