Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia

Study Overview
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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.

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.

Official Title
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Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia

Conditions
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Methicillin Susceptible Staphylococcus Aureus Septicemia, Bacteremia

Intervention / Treatment
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* Drug: Daptomycin
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>51 patients receiving a daily placebo infusion for five days on top of standard of care treatment for methicillin-sensitive Staphylococcus aureus (MSSA) bacteremia | Other: Placebo<br>* Placebo<br>|
| Experimental: Daptomycin<br>51 patients receiving daily daptomycin infusion for five days on top of standard of care treatment for MSSA bacteremia | Drug: Daptomycin<br>* Adjuvant therapy for up to five days<br>* Other names: Cubicin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood culture clearance | Time between first positive and first negative blood culture | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death from all causes (yes/no) | 30 days | 
| Adverse Reactions | Daptomycin adverse reactions | 5 days | 
| Intensive care admission | Admission to the intensive care unit (yes/no) | 30 days | 
| Metastatic infection | The development of a new deep seated infection (e.g. osteomyelitis, abscess, endocarditis) not present at time of initial bacteremia | 30 days | 
| Recurrent infection | The presence of a new positive blood culture occurring after the first negative culture and within 30 days of the initial positive | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Staphylococcus aureus, Bacteremia, Daptomycin