Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

Pfizer

Status: Completed

Conditions: Complicated Skin and Skin Structure Infections; Community-Acquired Bacterial Pneumonia; Complicated Intra-abdominal Infections

Treatments: Drug: tigecycline

Study type: Observational

Funder types: Industry

Identifiers

NCT01072539

B1811040 (Other Identifier)

3074X1-4527

Details and patient eligibility

About

The primary objective of this study is to identify any changes on the safety profile of adverse events and serious adverse events. And the secondary objective is to evaluate clinical response in the clinically evaluable population at test-of cure (TOC) or at the end of treatment (EOT) assessment, and microbiologic response at the subject level, if available.

Full description

Prior to the conduct of this study, the investigator will explain the study objective, etc to prospective subjects on the basis of "explanatory material." The informed consent will be obtained in written form by each subject voluntarily.

Enrollment: 3,172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :

Adults 18 years of age or older, who have one of the followings:

• Complicated skin and skin structure infections
• Complicated intra-abdominal infections
• Community-acquired bacterial pneumonia

Exclusion criteria

Subjects presenting with any of the following will not be included in the study:

• Patients who have known hypersensitivity to tigecycline
• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption

Trial design

3,172 participants in 1 patient group

Patients who have approved indications of Tygacil

Description:

Approved indications of Tygacil -complicated intraabdominal infection, complicated skin and skin structure infection, community-acquired bacterial pneumonia

Treatment:

Drug: tigecycline