Trials / Completed
CompletedNCT01072539
Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
A Post-marketing Surveillance (Pms) Study Of Safety And Effectiveness In Patients With Tigecycline Treatment
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,172 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Complicated Skin and Skin Structure Infections
- Complicated Intra-abdominal Infections
- Community-Acquired Bacterial Pneumonia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tigecycline | As prescribed by physician in usual clinical practice |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2015-04-01
- Completion
- 2015-04-01
- First posted
- 2010-02-22
- Last updated
- 2023-12-29
- Results posted
- 2016-05-30
Locations
36 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01072539. Inclusion in this directory is not an endorsement.