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New treatment option for Staphylococcus Aureus Bacteremia
Official title Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
ClinicalTrials.gov ID: NCT04886284
What this study is testing
What is Ertapenem?
Ertapenem is an investigational medicine, being studied as a potential treatment for staphylococcus aureus bacteremia.
Also referred to as Invanz.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- The participant must fulfil all inclusion and
You likely can't join if
- for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria to be eligible for this sub-study: Inclusion Criteria:
- 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...
- 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...
See the full eligibility criteria
- The participant must fulfil all inclusion and
- for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria to be eligible for this sub-study: Inclusion Criteria:
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Hamilton, Ontario, Canada
- Saint Catharines, Ontario, Canada
- Laval, Quebec, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Hamilton, Ontario, Canada; Saint Catharines, Ontario, Canada; Laval, Quebec, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.