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NCT00401960 · ClinicalTrials.gov registry record · Phase 4
Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis.
A Phase 4 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 6
- Enrollment target
NCT00401960 is a Phase 4 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 6 participants.
The verdict
NCT00401960, a Phase 4 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 6 participants
- Enrollment target
Study 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: 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.
Interventions
- DRUG Daptomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2006-09 |
| Est. Completion | 2008-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00401960
The ClinicalTrials.gov registry entry for NCT00401960 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Daptomycin is the first listed.
NCT00401960 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00401960 about?
NCT00401960 is a clinical study titled "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/kilog...
What is the current status of trial NCT00401960?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2006-09. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00401960?
The interventions under investigation include: Daptomycin (DRUG).
Who is sponsoring clinical trial NCT00401960?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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