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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01314053
First received: March 10, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

March 10, 2011
March 10, 2011
February 2011
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No Changes Posted
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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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample

Hospitalized patients who are prescribed daptomycin as part of required medical care for gram positive infections as deemed necessary by his/her treating physician.

Serious Gram-positive Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
April 2011
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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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01314053
99084
No
Wen-Sen Lee, Department of Infectious Disease, WanFang Hospital
Taipei Medical University WanFang Hospital
Not Provided
Principal Investigator: Wen-Sen Lee Taipei Medical University WanFang Hospital
Taipei Medical University WanFang Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP