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NCT01301638 Clinical Trial

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

Bacteremia Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01301638
Other study ID # 099150-E
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 21, 2011
Last updated February 22, 2011
Start date February 2011

Study information
Verified date February 2011
Source Far Eastern Memorial Hospital
Contact Men_Shan Hsu, Medicine
Phone 886277281849
Is FDA regulated No
Health authority Taiwan: Far Eastern Memorial hospital Research Ethics Review Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Far Eastern Memorial Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

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