Retrospective Evaluation of Safety and Efficacy of Daptomycin Used in Patients With Serious Gram-positive Infections
Retrospective Evaluation of Safety and Efficacy of Daptomycin Used in Patients With Serious Gram-positive Infections
Daptomycin was approved since 2005 in Taiwan and have been studied and published in west
 countries. After review the published papers, the few data were described in the Asian
 countries or Taiwan. The objectives of this study are to evaluate the efficacy and safety of
 daptomycin for the treatment of Gram-positive infections under actual conditions of use, and
 to understand other information concerned with daptomycin prescription. This study represents
 an opportunity for acquiring real world data on daptomycin usage, and may provide physicians
 in Taiwan with the information of characteristic of the patients receiving daptomycin and to
 evaluate outcomes. It also provides a means to identify safety signals that emerge with
 clinical usage.
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.
Inclusion Criteria:

 -  Patients started daptomycin therapy since January 2009.

 -  Patients completed daptomycin therapy by the end of December 2010.

 -  Patients had Gram positive infections.

 -  Patients received daptomycin therapy for at least 3 days.

 Exclusion Criteria:

 -  Daptomycin therapy will be chosen by the treating physician based on clinical
 indication and it is expected that risks of therapy will have already been considered.

 -  subjects are only to be excluded if he/she was enrolled in any antibiotics clinical
 trial during daptomycin treatment.