Status:
WITHDRAWN
Safety and Efficacy Study of CUBICIN (Daptomycin) Under Conditions of Actual Use
Lead Sponsor:
AstraZeneca
Conditions:
Complicated Skin and Skin Structure Infections and Bacteremia Including Right-sided Endocarditis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to monitor the safety and efficacy of CUBICIN under conditions of actual use in patients who are diagnosed with complicated Skin and Skin Structure infection (cSSI) or Sta...
Eligibility Criteria
Inclusion
- Diagnosis of cSSSI known or suspected to be due to gram-positive bacteria
- Diagnosis of right-sided endocarditis with one or more positive culture for S. aureus within two days prior to initiation of medication
- Prescribed daptomycin by patient's attending physician
Exclusion
- Known allergic or serious adverse reaction to daptomycin
- Patients with pneumonia
- Patients with baseline CPK values \>1000 U/L or 5x ULN
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01219114
Start Date
October 1 2010
End Date
November 1 2013
Last Update
September 28 2011
Active Locations (5)
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1
Research Site
Lipa City, Batangas, Philippines
2
Research Site
Davao City, Davao Region, Philippines
3
Research Site
Iloilo City, Iloilo, Philippines
4
Research Site
Pasig, National Capital Region, Philippines