CompletedNot Applicable

Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

South Korea3,172 participantsStarted 2010-05

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs

Timeframe: From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.

Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics

Trial details

NCT IDNCT01072539

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-04

Results submitted2016-04-21

View on ClinicalTrials.gov More Complicated Skin and Skin Structure Infections trials