Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00401960
Status:
TERMINATED
Last Update Posted:
2017-05-03
First Post:
2006-11-20
Brief Title:
Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
inadequate enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 milligramskilogramday 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None