Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia

Phase 4

Completed

• Conditions: Methicillin Susceptible Staphylococcus Aureus Septicemia; Bacteremia
• Interventions: Other: Placebo; Drug: Daptomycin

• Registration Number: NCT02972983
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-25
• Study Start: 2016-12-01
• Primary Completion: 2019-07
• Study Completion: 2019-09
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-18
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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
Daptomycin	Daptomycin	51 patients receiving daily daptomycin infusion for five days on top of standard of care treatment for MSSA bacteremia

Primary Outcome Measures

Name	Time	Method
Blood culture clearance	5 days	Time between first positive and first negative blood culture

Secondary Outcome Measures

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

Trial Locations

Locations (1)

McGill University Health Centre (Royal Victoria Hospital, Montreal Neurological Hospital, and Montreal General Hospital); 🇨🇦 Montreal, Quebec, Canada