Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-09-30

Brief Summary

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The purpose of our study is to examine the effects of a second antibiotic, daptomycin, in combination with a beta lactam antibiotic on treating bloodstream infection caused by methicillin-susceptible S. aureus.

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Detailed Description

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When patients have a blood infection with methicillin-susceptible S. aureus, they will all be treated with the usual standard of care, including abeta-lactam antibiotic, have their blood tested daily for the presence of the infection until they test negative, as well as an ultrasound of the heart to rule out an infection of the heart valves, as well as have any catheters removed (if possible) to ensure adequate control of the infection.

This study involves adding a second antibiotic, daptomycin, to the treatment regimen of half of the patients enrolled in this study. Daptomycin is approved by Health Canada for treating blood infections due to Staphylococcus aureus. It is currently not used in combination with a beta-lactam for these infections because there is insufficient evidence of benefit to justify the cost.

The study participants will receive an additional daily iv therapy which will consist of either daptomycin or a placebo for a total of five days while admitted to the hospital. During this time, the participants will continue to have their blood drawn to assess for the presence of bacteria. The participants' liver and muscle enzymes will also be measured on the first and fifth day of therapy to test for potential side effects of the daptomycin.

Conditions

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Methicillin Susceptible Staphylococcus Aureus Septicemia Bacteremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

51 patients receiving a daily placebo infusion for five days on top of standard of care treatment for methicillin-sensitive Staphylococcus aureus (MSSA) bacteremia

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Daptomycin

51 patients receiving daily daptomycin infusion for five days on top of standard of care treatment for MSSA bacteremia

Group Type EXPERIMENTAL

Daptomycin

Intervention Type DRUG

Adjuvant therapy for up to five days

Interventions

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Daptomycin

Adjuvant therapy for up to five days

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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Cubicin

Eligibility Criteria

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Inclusion Criteria

* Patient has a methicillin susceptible Staphylococcus aureus bacteremia.

Exclusion Criteria

* Underlying terminal illness
* Significant contraindication to beta-lactam therapy (i.e. severe allergy, severe adverse drug reaction)
* Expected death before 5 days
* Microbiologically confirmed need for concomitant VANCOMYCIN or DAPTOMYCIN

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No