Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis.
Primary Purpose
Endocarditis, Bacterial
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Daptomycin
Sponsored by
About this trial
This is an interventional treatment trial for Endocarditis, Bacterial focused on measuring Enterococcus, Daptomycin, Endocarditis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- NewYork-Presbyterian Hospital, Weill Cornell Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Daptomycin adjunctive group
standard of care
Arm Description
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
Patients with enterococcal endocarditis who elect to receive standard of care therapy as prescribed by their primary physician
Outcomes
Primary Outcome Measures
Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)
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
Number of Participants with creatine kinase elevation > 3x upper limit of normal or elevations of serum Cr >= 30% above baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT00401960
First Posted
November 20, 2006
Last Updated
April 6, 2017
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT00401960
Brief Title
Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis.
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
inadequate enrollment
Study Start Date
September 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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:
Safety.
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.
Efficacy.
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocarditis, Bacterial
Keywords
Enterococcus, Daptomycin, Endocarditis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daptomycin adjunctive group
Arm Type
Experimental
Arm Description
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
Arm Title
standard of care
Arm Type
No Intervention
Arm Description
Patients with enterococcal endocarditis who elect to receive standard of care therapy as prescribed by their primary physician
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Other Intervention Name(s)
Cubicin
Intervention Description
daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving for native valve enterococcal endocarditis
Primary Outcome Measure Information:
Title
Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)
Description
Number of Participants any Grade 3 or 4 toxicity (DAIDS scale); please see adverse event table for details
Time Frame
weekly
Title
Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria
Description
Number of Participants with creatine kinase elevation > 3x upper limit of normal or elevations of serum Cr >= 30% above baseline
Time Frame
weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu Y Rhee, MD, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NewYork-Presbyterian Hospital, Weill Cornell Campus
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This was a pilot single arm study, for which IPD are not pertinent
Learn more about this trial
Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis.
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