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

NCT ID: NCT00401960

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-10-31

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:

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Daptomycin adjunctive group

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

Group Type: EXPERIMENTAL

Daptomycin

Intervention Type: DRUG

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

standard of care

Patients with enterococcal endocarditis who elect to receive standard of care therapy as prescribed by their primary physician

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Daptomycin

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

Intervention Type: DRUG

Other Intervention Names

Cubicin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Rhee, Kyu Y.

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyu Y Rhee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

NewYork-Presbyterian Hospital, Weill Cornell Campus

New York, New York, United States

Countries

United States

Other Identifiers

0507008023

Identifier Type: -

Identifier Source: org_study_id