Retrospective Evaluation of Safety and Efficacy of Daptomycin Used in Patients With Serious Gram-positive Infections

Tracking Information
First Submitted Date	March 10, 2011
First Posted Date	March 14, 2011
Last Update Posted Date	March 14, 2011
Study Start Date	February 2011
Primary Completion Date	Not Provided
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Retrospective Evaluation of Safety and Efficacy of Daptomycin Used in Patients With Serious Gram-positive Infections
Official Title	Retrospective Evaluation of Safety and Efficacy of Daptomycin Used in Patients With Serious Gram-positive Infections
Brief Summary	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.
Detailed Description	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
Study Design	Observational Model: Case-Only; Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Hospitalized patients who are prescribed daptomycin as part of required medical care for gram positive infections as deemed necessary by his/her treating physician.
Condition	Serious Gram-positive Infections
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Unknown status
Estimated Enrollment; (submitted: March 10, 2011)	60
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	April 2011
Primary Completion Date	Not Provided
Eligibility Criteria	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Taiwan
Removed Location Countries
Administrative Information
NCT Number	NCT01314053
Other Study ID Numbers	99084
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Wen-Sen Lee, Department of Infectious Disease, WanFang Hospital
Study Sponsor	Taipei Medical University WanFang Hospital
Collaborators	Not Provided
Investigators	Principal Investigator: Wen-Sen Lee Taipei Medical University WanFang Hospital
PRS Account	Taipei Medical University WanFang Hospital
Verification Date	March 2011