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Carbapenem

Cefazolin + Ertapenem for Staph Bacteremia (CERT Trial)

Phase 2
Recruiting
Led By Emily G McDonald, MD MSc
Research Sponsored by Todd C. Lee MD MPH FIDSA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult >=18 years old
Be older than 18 years old
Must not have
Any receipt of valproic acid
Known seizure disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between days 6 and 90 inclusive

Summary

This trial tests if adding the antibiotic ertapenem to cefazolin can better treat severe bloodstream infections caused by MSSA. It aims to help patients who still face high death rates with current treatments by using two antibiotics that attack the bacteria in different ways. Ertapenem and cefazolin have been used together to successfully treat persistent MSSA bacteremia, showing potential synergy in studies.

Who is the study for?
Adults over 18 with a recent S. aureus blood infection, who are either on cefazolin or can switch to it. Excluded if they have improved with negative cultures, severe beta-lactam allergy, seizure disorders, expected mortality within 48 hours, or critical care needs but 'do not resuscitate' status.
What is being tested?
This trial tests whether adding Ertapenem to Cefazolin treatment improves outcomes in patients with methicillin-susceptible Staphylococcus aureus bacteremia compared to a placebo group.
What are the potential side effects?
Potential side effects may include allergic reactions (possibly anaphylaxis), gastrointestinal issues like diarrhea, potential for seizures in predisposed individuals, and possible interference with other medications like valproic acid.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken valproic acid.
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I have a known seizure disorder.
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I have shown improvement and had a negative culture result after 24 hours.
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I need intensive care but have chosen not to be resuscitated.
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I do not have a reliable way to be contacted by phone, email, or text.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between days 6 and 90 inclusive
This trial's timeline: 3 weeks for screening, Varies for treatment, and between days 6 and 90 inclusive for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical success
Secondary study objectives
Acute Kidney Injury
All cause-mortality
Blood culture clearance
+8 more
Other study objectives
Health-related quality of life

Side effects data

From 2009 Phase 4 trial • 23 Patients • NCT00535652
20%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ertapenem

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ErtapenemExperimental Treatment1 Intervention
Ertapenem 1g IV daily infused over 2 hours x 5 days
Group II: PlaceboPlacebo Group1 Intervention
Saline placebo infused daily over 2 hours x 5 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ertapenem
2011
Completed Phase 4
~8070

Find a Location

Who is running the clinical trial?

Todd C. Lee MD MPH FIDSALead Sponsor
2 Previous Clinical Trials
600 Total Patients Enrolled
2 Trials studying Staphylococcus Aureus Endocarditis
600 Patients Enrolled for Staphylococcus Aureus Endocarditis
Emily G McDonald, MD MScPrincipal InvestigatorResearch Institute of the McGill University Health Centre
4 Previous Clinical Trials
913 Total Patients Enrolled
1 Trials studying Staphylococcus Aureus Endocarditis
300 Patients Enrolled for Staphylococcus Aureus Endocarditis
Matthew P Cheng, MDPrincipal InvestigatorResearch Institute of the McGill University Health Centre
~18 spots leftby Apr 2025
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