Status:
TERMINATED
Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis.
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Endocarditis, Bacterial
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of this study is to determine the safety and efficacy of daptomycin when used as an adjuvant agent to standard care in the treatment of proven native valve Enterococcal endocarditis. Patients ...
Eligibility Criteria
Inclusion
- Age 18 or over
- Definite Enterococcal endocarditis, as defined by modified Duke criteria
- Able to complete follow-up 3 and 6 weeks following completion of intravenous antibiotic therapy
Exclusion
- Pregnancy or breast feeding
- Creatine phosphokinase levels over two times the upper limit of normal
- Renal insufficiency or dialysis requirement.
- Presence of chronic indwelling bloodstream catheters or foreign body devices suspected as primary or secondary sites of enterococcal infection unamenable to removal or replacement
- Inability to discontinue or abstain from use of a HMG CoA reductase inhibitor during the study period.
- Hypersensitivity to any of the study medications.
- Any condition that, in the investigator's opinion, may interfere with protocol compliance including, but not limited to, active substance abuse and/or dementia.
- Prosthetic valve endocarditis
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00401960
Start Date
September 1 2006
End Date
October 1 2008
Last Update
May 3 2017
Active Locations (1)
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1
NewYork-Presbyterian Hospital, Weill Cornell Campus
New York, New York, United States, 10021