Retrospective Evaluation of Safety and Efficacy of Daptomycin Used in Patients With Serious Gram-positive Infections
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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
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Tracking Information | ||||
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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. |
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Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Retrospective |
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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. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment |
60 | |||
Original Estimated Enrollment | Same as current | |||
Estimated Study Completion Date | April 2011 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Taipei Medical University WanFang Hospital | |||
Verification Date | March 2011 |