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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: Clinical Trial Phase 4 study, sponsored by Weill Medical College of Cornell University.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of Participants any Grade 3 or 4 toxicity (DAIDS scale); please see adverse event table for details
Interventions
- DRUG Daptomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2006-09 |
| Est. Completion | 2008-10 |
| Phase | Phase 4 |
Why NCT00401960 stopped before completion
NCT00401960 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Daptomycin is the first listed.
NCT00401960 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00401960's enrollment target sits among peer trials
6 1983rd of 2000 higher than 12 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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