Retrospective Evaluation of Safety and Efficacy of Daptomycin Used in Patients With Serious Gram-positive Infections
|ClinicalTrials.gov Identifier: NCT01314053|
Recruitment Status : Unknown
Verified March 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was: Active, not recruiting
First Posted : March 14, 2011
Last Update Posted : March 14, 2011
|Condition or disease|
|Serious Gram-positive Infections|
This is a retrospective, non-comparative study, which will be performed after obtaining permission from the institutional review board. Patients with serious gram-positive infections who had received daptomycin from January 2009 and completed daptomycin therapy by the end of December 2010 will be screened, and patients who received ≥ 3 days of daptomycin will be identified eligible to be included. Eligible patients' medical records will be reviewed.
As this is a retrospective chart review, it is expected that informed consent will not be necessary. For patients' confidentiality concern, patients' name or chart number will not to be record in any part of Data Collection Form (APPENDIX 1). A patient identification number will be assigned to each patient included in this surveillance. A study coordinator at site will be identified, and hospital specific process will be utilized to identify patients. Information to be collected was shown on Data Collection Form (Appendix 1). After completing patient data collection, the efficacy and safety will be evaluated for the included cases.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Retrospective Evaluation of Safety and Efficacy of Daptomycin Used in Patients With Serious Gram-positive Infections|
|Study Start Date :||February 2011|
|Estimated Study Completion Date :||April 2011|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01314053
|Taipei Medical University - WanFang Hospital|
|Principal Investigator:||Wen-Sen Lee||Taipei Medical University WanFang Hospital|