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

NCT00401960 | Terminated Phase 4 Results DMC

• 1 other identifier: 0507008023
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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:

• Time to clearance of bacteremia
• Cure at 6 weeks following completion of antibiotic therapy
• Mortality at 6 weeks following completion of antibiotic therapy
• 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

Keywords

Enterococcus; Daptomycin; Endocarditis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)

  Number of Participants any Grade 3 or 4 toxicity (DAIDS scale); please see adverse event table for details

  weekly

• Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria

  Number of Participants with creatine kinase elevation \> 3x upper limit of normal or elevations of serum Cr \>= 30% above baseline

  weekly

Study Arms (2)

Daptomycin adjunctive group

EXPERIMENTAL

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

Drug: Daptomycin

standard of care

NO INTERVENTION

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

Interventions

Daptomycin DRUG

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

Also known as: Cubicin

Daptomycin adjunctive group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

NewYork-Presbyterian Hospital, Weill Cornell Campus

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Endocarditis, Bacterial; Endocarditis

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Cardiovascular Infections; Cardiovascular Diseases; Heart Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

study terminated due to insufficient enrollment; data therefore not analyzed

Results Point of Contact

• Title: K Rhee
• Organization: Weill Medical College

kyr9001@med.cornell.edu

6469626224

Study Officials

• Kyu Y Rhee, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 20, 2006
• First Posted: November 22, 2006
• Study Start: September 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 3, 2017
• Results First Posted: May 3, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)