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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 because the information has not been verified recently.
Verified February 2011 by Far Eastern Memorial Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01301638
First received: February 21, 2011
Last updated: February 22, 2011
Last verified: February 2011
History of Changes

February 21, 2011
February 22, 2011
February 2011
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Complete list of historical versions of study NCT01301638 on ClinicalTrials.gov Archive Site
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Retrospective Evaluation of Safety and Efficacy of Daptomycin Used in Patients With Serious Gram-positive Infections
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Before Daptomycin (Cubicin ®) approved by the U.S. FDA in 2003, There were large-scale clinical trials conducted that included more than 1,000 subjects and than Daptomycin got complicated skin and soft tissue infections (CSSSI) indication. After 2004, Daptomycin got new indications about bacteremia and endocarditis due to success outcomes in the clinical trial which included infected in blood flow and endocardial infected patients.

All subjects in Daptomycin clinical trials are European and American race. It is necessary that collecting safety and efficacy data of Daptomycin in Taiwan race. I will intent to evaluate the safety and efficacy of Daptomycin which were used in patients with serious gram-positive infections retrospectively. And the outcome could be a reference for Daptomycin future using.
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Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample

Before Daptomycin (Cubicin ®) approved by the U.S. FDA in 2003, There were large-scale clinical trials conducted that include more than 1,000 subjects and than Daptomycin got complicated skin and soft tissue infections (CSSSI) indication. After 2004, Daptomycin got new indications about bacteremia and endocarditis due to success outcomes in the clinical trial which included infected in blood flow and endocardial infected patients.

All subjects in Daptomycin clinical trials are European and American race. It is necessary that collecting safety and efficacy data of Daptomycin in Taiwan race. I will intent to evaluate the safety and efficacy of Daptomycin which were used in patients with serious gram-positive infections retrospectively. And the outcome could be a reference for Daptomycin future using
  • Bacteremia
  • Endocarditis
  • 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.
 
Not yet recruiting
50
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Inclusion Criteria:

  • Hospitalized patients who were prescribed daptomycin from 1st January 2009 to 31st December 2010 for gram positive infections as deemed necessary by his/her treating physician. And patients received Daptomycin therapy for at least 3 days.

Exclusion Criteria:

  • Patients received Daptomycin therapy for over 3 days
Both
18 Years and older
No
Contact: Men_Shan Hsu, Medicine 886277281849
Taiwan
 
NCT01301638
099150-E
No
Department of Internal Medicine, Section of Infectious Disease, Far Eastern Memorial Hospital
Far Eastern Memorial Hospital
Not Provided
Principal Investigator: Men_Shan Hsu, medicine Far Eastern Memorial Hospital
Far Eastern Memorial Hospital
February 2011

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