Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve 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:
- The frequency of any Grade 3 or 4 toxicity (DAIDS scale) will be measured.
- The frequency of muscle toxicity or renal toxicity, as determined by predefined criteria.
- Time to clearance of bacteremia
- Cure at 6 weeks following completion of antibiotic therapy
- Mortality at 6 weeks following completion of antibiotic therapy
- Peak and trough serum bactericidal titers
- The minimum bactericidal concentration of Enterococci to daptomycin
We expect to enroll 40 patients over 2 years.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|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|
- Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale) [ Time Frame: weekly ]Number of Participants any Grade 3 or 4 toxicity (DAIDS scale); please see adverse event table for details
- Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria [ Time Frame: weekly ]Number of Participants with creatine kinase elevation > 3x upper limit of normal or elevations of serum Cr >= 30% above baseline
|Study Start Date:||September 2006|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Experimental: Daptomycin adjunctive group
Patients with enterococcal endocarditis who elect to receive daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving
daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving for native valve enterococcal endocarditis
Other Name: Cubicin
No Intervention: standard of care
Patients with enterococcal endocarditis who elect to receive standard of care therapy as prescribed by their primary physician
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401960
|United States, New York|
|NewYork-Presbyterian Hospital, Weill Cornell Campus|
|New York, New York, United States, 10021|
|Principal Investigator:||Kyu Y Rhee, MD, PhD||Weill Medical College of Cornell University|