Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorTodd C. Lee MD MPH FIDSA

About this trial

There is a variety of in vitro, in vivo (animal model), and human case series data which suggests that the addition of ertapenem to cefazolin could improve outcomes in methicillin-susceptible S. aureus bacteremia. No randomized controlled trial has been performed.

This study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Adult >=18 years old

with any unknown MRSA status (in centers with <15% prevalence of MRSA in their annual blood cultures) or known negative MRSA screening swab within 90 days OR

which has already been shown to be MSSA

Current receipt of cefazolin or where it would be clinically appropriate (according to treating ID specialist) to switch to cefazolin as the backbone therapy (open label, non-study drug).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ertapenem

    Drug

    Adjunctive ertapenem

  • Placebo

    Drug

    Saline placebo

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ErtapenemExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical success

Composite of: Patient alive, fever resolved, blood cultures negative for S. aureus, systolic blood pressure \>=90mmHg not on vasopressors

Time frame
Day 5

Secondary outcomes

1

Blood culture clearance

Time between first positive and first negative blood culture

Time frame
30 days
2

Clinical improvement

Time to clinical improvement defined as the time until fever resolved, blood cultures sterile, and systolic blood pressure \>=90mmHg not on vasopressors in patients who survive to clinical improvement

Time frame
30 days
3

Length of stay

The time from initial emergency room visit until discharge from hospital in patients discharged alive

Time frame
90 days
4

All cause-mortality

Death from any cause

Time frame
90 days

Other outcomes

1

Health-related quality of life

This will be assessed using the EQ-5D-5L questionnaire

Time frame
90 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Todd C. Lee MD MPH FIDSA

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Sponsor institution