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Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis.

NCT00401960 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-05-03

Study results available
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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.

Conditions

  • Endocarditis, Bacterial

Interventions

DRUG

Daptomycin

daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving for native valve enterococcal endocarditis

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Kyu Y Rhee, MD, PhD · Weill Medical College of Cornell University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00401960 on ClinicalTrials.gov