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

This study has been terminated.
(inadequate enrollment)
Sponsor:
Information provided by (Responsible Party):
Rhee, Kyu Y., Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00401960
First received: November 20, 2006
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Endocarditis, Bacterial
Drug: Daptomycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • frequency of any Grade 3 or 4 toxicity (DAIDS scale) [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
  • frequency of muscle toxicity or renal toxicity, as determined by predefined criteria [ Time Frame: weekly ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: September 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401960

Locations
United States, New York
NewYork-Presbyterian Hospital, Weill Cornell Campus
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Kyu Y Rhee, MD, PhD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Rhee, Kyu Y., Assistant Professor, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00401960     History of Changes
Other Study ID Numbers: 0507008023
Study First Received: November 20, 2006
Last Updated: June 27, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Enterococcus
Daptomycin
Endocarditis

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014