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
  Purpose

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
Bacteremia
Endocarditis
Serious Gram-positive Infections

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Estimated Enrollment: 50
Study Start Date: February 2011
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: February 21, 2011
Last Updated: February 22, 2011
Health Authority: Taiwan: Far Eastern Memorial hospital Research Ethics Review Committee

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

ClinicalTrials.gov processed this record on October 22, 2014