Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

Condition(s) targeted: Complicated Skin and Skin Structure Infections; Complicated Intra-abdominal Infections; Community-Acquired Bacterial Pneumonia

Intervention: tigecycline (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Official title: A Post-marketing Surveillance (Pms) Study Of Safety And Effectiveness In Patients With Tigecycline Treatment

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

Count and frequency of occurrence of serious adverse event or unexpected adverse event by category

Count and frequency of occurrence of adverse events by patient baseline factor and by treatment factor to determine factors affecting the safety

Secondary outcome:

Clinical response of cure, (improvement), failure, or unevaluable in patients treated with Tygacil for the first time assessed by the investigator at the EOT(end of treatment) or TOC(test of cure) visit for each subject

A microbiologic response at the subject level, if available

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

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

Starting date: May 2010
Last updated: August 5, 2015