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

Endocarditis, Bacterial Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00401960
• Other study ID #: 0507008023
• Status: Terminated
• Phase: Phase 4
• First received: November 20, 2006
• Last updated: June 27, 2012
• Start date: September 2006
• Est. completion date: October 2008

Study information

• Verified date: June 2012
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial

Intervention

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

Locations

Country	Name	City	State
United States	NewYork-Presbyterian Hospital, Weill Cornell Campus	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of any Grade 3 or 4 toxicity (DAIDS scale)		weekly	Yes
Primary	frequency of muscle toxicity or renal toxicity, as determined by predefined criteria		weekly	Yes