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

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ClinicalTrials.gov Identifier: NCT01301638
Recruitment Status : Unknown
Verified February 2011 by Far Eastern Memorial Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2011
Last Update Posted : February 23, 2011
Sponsor:
Information provided by:
Far Eastern Memorial Hospital

Brief Summary:

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.


Condition or disease
Bacteremia Endocarditis Serious Gram-positive Infections

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Study Start Date : February 2011




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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

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): NCT01301638


Contacts
Contact: Men_Shan Hsu, Medicine 886277281849

Locations
Taiwan
Far Eastern Memorial Hospital Not yet recruiting
Taipei, Taiwan, 220
Contact: Men_Shan Hsu, Medicine degree    886-2-7728-1849      
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Men_Shan Hsu, medicine Far Eastern Memorial Hospital

Responsible Party: Department of Internal Medicine, Section of Infectious Disease, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01301638     History of Changes
Other Study ID Numbers: 099150-E
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Infection
Bacteremia
Endocarditis
Bacterial Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases