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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01314053
First Posted: March 14, 2011
Last Update Posted: March 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Taipei Medical University WanFang Hospital
  Purpose
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.

Condition
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.

  Eligibility

Information from the National Library of Medicine

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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.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01314053


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

Responsible Party: Wen-Sen Lee, Department of Infectious Disease, WanFang Hospital
ClinicalTrials.gov Identifier: NCT01314053     History of Changes
Other Study ID Numbers: 99084
First Submitted: March 10, 2011
First Posted: March 14, 2011
Last Update Posted: March 14, 2011
Last Verified: March 2011

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents