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Carbapenem

Ertapenem for Staphylococcal Sepsis (CERT Trial)

Phase 2
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between days 6 and 90 inclusive
Awards & highlights

CERT Trial Summary

This trial will test if adding the antibiotic ertapenem to cefazolin improves outcomes in people with methicillin-susceptible S. aureus bacteremia.

Eligible Conditions
  • Staphylococcal Septicemia
  • Staphylococcal Sepsis
  • Staph Bacteremia
  • Staphylococcus Aureus Endocarditis

CERT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical success
Secondary outcome measures
Acute Kidney Injury
All cause-mortality
Blood culture clearance
+8 more
Other outcome measures
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

CERT 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
Emily G McDonald, MD MScPrincipal InvestigatorResearch Institute of the McGill University Health Centre
3 Previous Clinical Trials
902 Total Patients Enrolled
Matthew P Cheng, MDPrincipal InvestigatorResearch Institute of the McGill University Health Centre

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If a patient is under 55 years, do they qualify for this experiment?

"According to the guidelines set out by this clinical trial, the minimum age requirement for enrollment is 18 years old while the maximum age limit is 100 years old."

Answered by AI

Could you explain the possible side effects of Ertapenem?

"Ertapenem's safety was estimated to be a 2. This is because it is only in Phase 2 trials, meaning that while there are some data supporting its safety, there is currently no evidence of efficacy."

Answered by AI

Are there previous studies that have involved Ertapenem?

"There are a total of 9 clinical trials underway for Ertapenem. Of these, 2 have reached Phase 3. Most of the research is located in Montreal, Quebec; however, there are 20 different sites running these medical studies."

Answered by AI

For what medical conditions is Ertapenem typically prescribed?

"Ertapenem can be used to effectively treat moderate, severe complicated intra-abdominal infections, abortion, septic, and moderate, severe community acquired pneumonia (cap)."

Answered by AI

Are recruitment efforts for this trial ongoing?

"As can be seen on clinicaltrials.gov, this trial is no longer recruiting patients. The last update to the posting was on February 21st, 2022 and the study originally went up on July 1st, 2020. Although this particular trial has finished enrolling patients, there are still 223 other studies that are looking for participants."

Answered by AI

How do I qualify to take part in this experiment?

"This trial is looking for 60 patients who have staphylococcus aureus septicemia and meet the following criteria: they must be adults over 18 years old, with an unknown MRSA status or a known negative MRSA screening swab within 90 days, and they must be currently receiving cefazolin or it must be clinically appropriate for them to switch to cefazolin. Up to 24 additional 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"

Answered by AI

How many people are being invited to participate in this clinical trial?

"As of February 21st, 2022, this study is no longer looking for new patients to enrol. This particular clinical trial was posted on July 1st, 2020 but has since been updated. There are currently 214 other trials involving staphylococcus aureus septicemia that are still recruiting and 9 Ertapenem studies also have open enrolment periods."

Answered by AI
Recent research and studies
~22 spots leftby Apr 2025