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

Phase 4

Terminated

• Conditions: Endocarditis, Bacterial
• Interventions: Drug: Daptomycin

• Registration Number: NCT00401960
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-11-20
• Study First Submitted QC: 2006-11-20
• Study First Posted: 2006-11-22
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2016-12-29
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-06
• Last Update Submitted: 2017-04-06
• Results First Posted: 2017-05-03
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daptomycin adjunctive group	Daptomycin	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)	weekly	Number of Participants any Grade 3 or 4 toxicity (DAIDS scale); please see adverse event table for details
Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria	weekly	Number of Participants with creatine kinase elevation \> 3x upper limit of normal or elevations of serum Cr \>= 30% above baseline

Trial Locations

Locations (1)

NewYork-Presbyterian Hospital, Weill Cornell Campus; 🇺🇸 New York, New York, United States