Cefazolin and Ertapenem Salvage Therapy Rapidly Clears Persistent Methicillin-Susceptible Staphylococcus aureus Bacteremia.
Erlinda R Ulloa, Kavindra V Singh, Matthew Geriak...
https://pubmed.ncbi.nlm.nih.gov/31773134Actively Recruiting
Phase 2
Age: 18Years - 100Years
All Genders
ID04886284
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia (CERT)
Led by Todd C. Lee MD MPH FIDSA · Updated on 2026-05-27
60
Participants Needed
6
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether adding ertapenem to cefazolin improves treatment outcomes in adults with methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia. This phase 2 randomized controlled trial builds on previous laboratory and animal studies, as well as small human case series, suggesting potential benefits of this drug combination. The study is a sub-study of the larger Staphylococcus aureus Network Adaptive Platform (SNAP) trial and aims to explore clinical success rates by day 5 of treatment. Participants receive either ertapenem 1 gram intravenously once daily infused over 2 hours for 5 days alongside cefazolin or a saline placebo infused daily over 2 hours for 5 days with cefazolin as standard therapy. The study uses quadruple masking to compare the effects of ertapenem plus cefazolin against cefazolin with placebo. The trial will monitor a variety of secondary outcomes including blood culture clearance at 30 days, clinical improvement, length of hospital stay, mortality, and infection complications over periods up to 90 days. Throughout the study, participants will have blood cultures and clinical assessments to evaluate infection clearance and treatment response. Researchers will also monitor for adverse events such as acute kidney injury or seizures within the first week. The total participation timeframe includes outcome assessments up to 90 days after treatment starts. This comprehensive monitoring will help determine if the combination therapy reduces bacteremia duration and improves patient outcomes without increasing risks.
CONDITIONS
Brief Title
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Who Can Participate
Age: 18Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adult aged 18 years or older
- Diagnosed with Staphylococcus aureus bacteremia within the past 48 hours
- MRSA status unknown in centers with less than 15% MRSA prevalence or known negative MRSA screening within 90 days, or confirmed MSSA
- Currently receiving cefazolin or it is clinically appropriate to switch to cefazolin as main therapy
- Up to 12-24 hours of vancomycin, linezolid, or daptomycin allowed if there is sepsis and MRSA has not been excluded
You will not qualify if you...
- Clinically improved with at least one negative culture after 24 hours incubation at recruitment
- History of anaphylaxis to any beta-lactam antibiotic or allergy to ertapenem
- Polymicrobial bacteremia excluding skin commensals
- Known seizure disorder
- Current or recent use of valproic acid
- Expected mortality within 48 hours
- Need for critical care but "do not resuscitate" status prevents critical care
- Unable to provide informed consent and no healthcare proxy available
- Refusal to provide informed consent or healthcare team refusal to participate
- No reliable outpatient contact method
- Previously enrolled in the study
- Isolate identified as MRSA after enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5 days
Participants receive daily intravenous infusions of either ertapenem or saline placebo for 5 days alongside cefazolin therapy.
5 daily visits (in-person)
Follow-up
Duration - Up to 90 days
Participants are monitored and assessed for clinical success, blood culture clearance, and other health outcomes up to 90 days after treatment.
Multiple follow-up visits up to 90 days
Trial Site Locations
Total: 6 locations
1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N4Z6
Actively Recruiting
2
Hamilton Health Sciences (Hamilton General Hospital and Juravinski Hospital)
Hamilton, Ontario, Canada, L8P1A2
Actively Recruiting
3
Niagara Health - St. Catharines site
Saint Catharines, Ontario, Canada, L2E6X2
Actively Recruiting
4
Hospital de la Cité de la Sante
Laval, Quebec, Canada
Actively Recruiting
5
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
6
McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
Montreal, Quebec, Canada, H4A3J1
Actively Recruiting
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Research Team
L
Lina Petrella
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Cefazolin and Ertapenem, a Synergistic Combination Used To Clear Persistent Staphylococcus aureus Bacteremia.
George Sakoulas, Joshua Olson, Juwon Yim...
https://pubmed.ncbi.nlm.nih.gov/27572414Initial low-dose gentamicin for Staphylococcus aureus bacteremia and endocarditis is nephrotoxic.
Sara E Cosgrove, Gloria A Vigliani, Vance G Fowler...
https://pubmed.ncbi.nlm.nih.gov/19207079Effects of neutrophils on cefazolin activity and penicillin-binding proteins in Staphylococcus aureus abscesses.
David M Bamberger, Betty L Herndon, Jeffrey Fitch...
https://pubmed.ncbi.nlm.nih.gov/12183241Binding of beta-lactam antibiotics to penicillin-binding proteins in methicillin-resistant Staphylococcus aureus.
H F Chambers, M Sachdeva
https://pubmed.ncbi.nlm.nih.gov/2345297Adjunctive Daptomycin in the Treatment of Methicillin-susceptible Staphylococcus aureus Bacteremia: A Randomized, Controlled Trial.
Matthew P Cheng, Alexander Lawandi, Guillaume Butler-Laporte...
https://pubmed.ncbi.nlm.nih.gov/32667982The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe.
Steven Y C Tong, Jocelyn Mora, Asha C Bowen...
https://pubmed.ncbi.nlm.nih.gov/35717634Incidence and factors associated with rapid blood culture sterilization among patients receiving ertapenem combination therapy for MSSA bacteremia.
Sunish Shah, Lloyd G Clarke, Bonnie A Falcione...
https://pubmed.ncbi.nlm.nih.gov/41433510