At a glance
ClinicalIndex Comparison RecordN/ACompleted· 3,172 enrolled
Drug / intervention
tigecyclinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Post-marketing Surveillance (Pms) Study Of Safety And Effectiveness In Patients With Tigecycline Treatment
In Brief
An observational study evaluating tigecycline for Complicated Skin and Skin Structure Infections and 2 related conditions. Completed, enrolled 3,172 participants across 36 sites.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsComplicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections, Community-Acquired Bacterial Pneumonia
CountriesSouth Korea
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2010
Enrollment StartMay 2010
Primary CompletionApr 2015
TodayJul 2026
First PostedFeb 22, 2010
Enrollment StartMay 1, 2010
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 16.4 years ago
Interventions
tigecyclinedrug
As prescribed by physician in usual clinical practice