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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Active, not recruiting
Information provided by:
Taipei Medical University WanFang Hospital Identifier:
First received: March 10, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
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.

Serious Gram-positive Infections

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Evaluation of Safety and Efficacy of Daptomycin Used in Patients With Serious Gram-positive Infections

Resource links provided by NLM:

Further study details as provided by Taipei Medical University WanFang Hospital:

Estimated Enrollment: 60
Study Start Date: February 2011
Estimated Study Completion Date: April 2011
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.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01314053

Taipei Medical University - WanFang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Principal Investigator: Wen-Sen Lee Taipei Medical University WanFang Hospital
  More Information

Responsible Party: Wen-Sen Lee, Department of Infectious Disease, WanFang Hospital Identifier: NCT01314053     History of Changes
Other Study ID Numbers: 99084
Study First Received: March 10, 2011
Last Updated: March 10, 2011

Keywords provided by Taipei Medical University WanFang Hospital:
Serious Gram-positive Infections

Additional relevant MeSH terms:
Communicable Diseases
Anti-Bacterial Agents
Anti-Infective Agents processed this record on May 24, 2017