Endocarditis, Bacterial Clinical Trial
Official title:
Open Label Study to Assess the Efficacy and Safety of Daptomycin in Combination With Anti-Cell Wall Active Therapy in the Treatment of Enterococcal Endocarditis
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 with this disease will be offered the option of receiving daptomycin
at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already
receiving. The hypothesis of this study is that daptomycin added to standard therapy for
Enterococcal endocarditis is safe and efficacious.
Patients who receive daptomycin + standard therapy will be compared to patients who receive
standard therapy alone with respect to the following outcomes:
1. Safety.
1. The frequency of any Grade 3 or 4 toxicity (DAIDS scale) will be measured.
2. The frequency of muscle toxicity or renal toxicity, as determined by predefined
criteria.
2. Efficacy.
1. Clinical efficacy.
- Time to clearance of bacteremia
- Cure at 6 weeks following completion of antibiotic therapy
- Mortality at 6 weeks following completion of antibiotic therapy
2. Microbiologic efficacy.
- Peak and trough serum bactericidal titers
- The minimum bactericidal concentration of Enterococci to daptomycin
We expect to enroll 40 patients over 2 years.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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