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

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

Completed

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Key information

Conditions

Complicated Skin and Skin Structure Infections Complicated Intra-abdominal Infections Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site

Manila, Philippines

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tigecycline (Tygacil)

Drug

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 outcomes

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?"

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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)

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: May 23, 2008
Registry last updated: Jul 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed