Status:
RECRUITING
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Lead Sponsor:
Todd C. Lee MD MPH FIDSA
Conditions:
Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Septicemia
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
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. aureu...
Detailed Description
Cefazolin is licensed in Canada for the management of infections due to susceptible Staphylococcus aureus, including bacteremia. It has been commonly used for decades in this disease and, when compare...
Eligibility Criteria
Inclusion
- The participant must fulfil all inclusion and exclusion criteria for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria to be eligible for this sub-study:
- Adult \>=18 years old
- S. aureus bacteremia within the past 48 hours:
- 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).
- NOTE: Up to an additional 12-24 hours of open label non-study VANCOMYCIN, LINEZOLID or DAPTOMYCIN may be allowed if there is sepsis and clinical concern for MRSA has not been excluded.
Exclusion
- Clinical:
- At time of recruitment, the patient has already clinically improved with at least one subsequent negative culture at \>24 hours incubation
- Anaphylaxis to any beta-lactam antibiotic (and any allergy to ertapenem) Polymicrobial bacteremia (not including skin commensals)
- Known seizure disorder
- Any receipt of valproic acid
- Expected mortality within 48 hours
- Need for critical care resources but "do not resuscitate" status precludes the receipt of critical care
- Unable to provide informed consent and no available healthcare proxy (with ethics approval for deferred consent in cases of severe illness)
- Administrative:
- Refusal to provide informed consent
- Refusal of healthcare team to participate
- No reliable means of outpatient contact (telephone/email/text)
- Previously enrolled
- Patients whose isolate is identified as MRSA post-enrollment will be subsequently excluded (see below).
- Note that because MSSA is much more common than MRSA in Canada (90% of all S. aureus bacteremia at MUHC, for example, are MSSA and in the presence of a negative MRSA screening swab or unknown MRSA status, this means that the risk of MRSA is less than 5%). We believe time to combination therapy is likely linked to benefit, therefore we will recruit the patients as soon as S. aureus is identified but potentially prior to confirmation the organism is MSSA. Where possible, rapid MRSA detection techniques will be deployed; however with conventional screening this will mean approximately a 12-24 hours delay. Organisms subsequently identified as MRSA will be excluded from the intention to treat analysis and the sample size will be adjusted accordingly to ensure the total enrollment meets study goals.
Key Trial Info
Start Date :
May 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04886284
Start Date
May 20 2024
End Date
July 1 2026
Last Update
August 15 2025
Active Locations (5)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N4Z6
2
Hamilton Health Sciences (Hamilton General Hospital and Juravinski Hospital)
Hamilton, Ontario, Canada, L8P1A2
3
Niagara Health - Niagara Falls Site
Niagara Falls, Ontario, Canada, L2E6X2
4
Hospital de la Cité de la Sante
Laval, Quebec, Canada