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New combo therapy aims to beat staph blood infections
NCT ID NCT04886284
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding the antibiotic ertapenem to standard cefazolin treatment improves outcomes for adults with methicillin-susceptible Staphylococcus aureus bloodstream infections. About 60 participants will receive either the combination or a placebo. The study measures clinical success, including fever resolution and blood culture clearance.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ertapenem (Invanz) added to cefazolin
- What this could lead to
- If it works, this could offer a more effective treatment for serious Staph bloodstream infections, potentially reducing complications and hospital stays.
- What could go wrong
- This is a small, early-phase trial with only 60 participants, so results may not apply broadly. Adding an antibiotic also raises risks of side effects and antibiotic resistance.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: Inclusion Criteria: 1. Adult \>=18 years old 2. 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 3. 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 Criteria: Clinical: 1. At time of recruitment, the patient has already clinically improved with at least one subsequent negative culture at \>24 hours incubation 2. Anaphylaxis to any beta-lactam antibiotic (and any allergy to ertapenem) Polymicrobial bacteremia (not including skin commensals) 3. Known seizure disorder 4. Any receipt of valproic acid 5. Expected mortality within 48 hours 6. Need for critical care resources but "do not resuscitate" status precludes the receipt of critical care 7. Unable to provide informed consent and no available healthcare proxy (with ethics approval for deferred consent in cases of severe illness) Administrative: 1. Refusal to provide informed consent 2. Refusal of healthcare team to participate 3. No reliable means of outpatient contact (telephone/email/text) 4. Previously enrolled 5. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Foothills Medical Centre
RECRUITINGCalgary, Alberta, T2N4Z6, Canada
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Hamilton Health Sciences (Hamilton General Hospital and Juravinski Hospital)
RECRUITINGHamilton, Ontario, L8P1A2, Canada
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Hospital de la Cité de la Sante
RECRUITINGLaval, Quebec, Canada
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Jewish General Hospital
RECRUITINGMontreal, Quebec, H3T 1E2, Canada
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McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
RECRUITINGMontreal, Quebec, H4A3J1, Canada
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Niagara Health - St. Catharines site
RECRUITINGSaint Catharines, Ontario, L2E6X2, Canada
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Surrey Memorial Hospital
RECRUITINGSurrey, British Columbia, Canada
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