NCT04886284

Brief Summary

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. No randomized controlled trial has been performed. This study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
2mo left

Started May 2024

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
May 2024Jul 2026

First Submitted

Initial submission to the registry

May 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
3 years until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

February 17, 2026

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

May 10, 2021

Last Update Submit

February 12, 2026

Conditions

Staphylococcus Aureus SepticemiaStaphylococcal SepsisStaphylococcus Aureus BacteremiaStaphylococcus Aureus Endocarditis

Keywords

Staphylococcus aureusMethicillin-susceptibleBacteremia

Outcome Measures

Primary Outcomes (1)

  • Clinical success

    Composite of: Patient alive, fever resolved, blood cultures negative for S. aureus, systolic blood pressure \>=90mmHg not on vasopressors

    Day 5

Secondary Outcomes (11)

  • Blood culture clearance

    30 days

  • Clinical improvement

    30 days

  • Length of stay

    90 days

  • All cause-mortality

    90 days

  • C. diff infection

    56 days

  • +6 more secondary outcomes

Other Outcomes (1)

  • Health-related quality of life

    90 days

Study Arms (2)

Ertapenem

EXPERIMENTAL

Ertapenem 1g IV daily infused over 2 hours x 5 days

Drug: Ertapenem

Placebo

PLACEBO COMPARATOR

Saline placebo infused daily over 2 hours x 5 days

Drug: Placebo

Interventions

ErtapenemDRUG

Adjunctive ertapenem

Also known as: Invanz
Ertapenem
PlaceboDRUG

Saline placebo

Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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 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.
  • Clinical:
  • 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:
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Foothills Medical Centre

Calgary, Alberta, T2N4Z6, Canada

RECRUITING

Hamilton Health Sciences (Hamilton General Hospital and Juravinski Hospital)

Hamilton, Ontario, L8P1A2, Canada

RECRUITING

Niagara Health - St. Catharines site

Saint Catharines, Ontario, L2E6X2, Canada

RECRUITING

Hospital de la Cité de la Sante

Laval, Quebec, Canada

RECRUITING

McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)

Montreal, Quebec, H4A3J1, Canada

RECRUITING

Related Publications (7)

  • Ulloa ER, Singh KV, Geriak M, Haddad F, Murray BE, Nizet V, Sakoulas G. Cefazolin and Ertapenem Salvage Therapy Rapidly Clears Persistent Methicillin-Susceptible Staphylococcus aureus Bacteremia. Clin Infect Dis. 2020 Sep 12;71(6):1413-1418. doi: 10.1093/cid/ciz995.

    PMID: 31773134BACKGROUND

  • Sakoulas G, Olson J, Yim J, Singh NB, Kumaraswamy M, Quach DT, Rybak MJ, Pogliano J, Nizet V. Cefazolin and Ertapenem, a Synergistic Combination Used To Clear Persistent Staphylococcus aureus Bacteremia. Antimicrob Agents Chemother. 2016 Oct 21;60(11):6609-6618. doi: 10.1128/AAC.01192-16. Print 2016 Nov.

    PMID: 27572414BACKGROUND

  • Cosgrove SE, Vigliani GA, Fowler VG Jr, Abrutyn E, Corey GR, Levine DP, Rupp ME, Chambers HF, Karchmer AW, Boucher HW. Initial low-dose gentamicin for Staphylococcus aureus bacteremia and endocarditis is nephrotoxic. Clin Infect Dis. 2009 Mar 15;48(6):713-21. doi: 10.1086/597031.

    PMID: 19207079BACKGROUND

  • Bamberger DM, Herndon BL, Fitch J, Florkowski A, Parkhurst V. Effects of neutrophils on cefazolin activity and penicillin-binding proteins in Staphylococcus aureus abscesses. Antimicrob Agents Chemother. 2002 Sep;46(9):2878-84. doi: 10.1128/AAC.46.9.2878-2884.2002.

    PMID: 12183241BACKGROUND

  • Chambers HF, Sachdeva M. Binding of beta-lactam antibiotics to penicillin-binding proteins in methicillin-resistant Staphylococcus aureus. J Infect Dis. 1990 Jun;161(6):1170-6. doi: 10.1093/infdis/161.6.1170.

    PMID: 2345297BACKGROUND

  • Cheng MP, Lawandi A, Butler-Laporte G, De l'Etoile-Morel S, Paquette K, Lee TC. Adjunctive Daptomycin in the Treatment of Methicillin-susceptible Staphylococcus aureus Bacteremia: A Randomized, Controlled Trial. Clin Infect Dis. 2021 May 4;72(9):e196-e203. doi: 10.1093/cid/ciaa1000.

    PMID: 32667982BACKGROUND

  • Tong SYC, Mora J, Bowen AC, Cheng MP, Daneman N, Goodman AL, Heriot GS, Lee TC, Lewis RJ, Lye DC, Mahar RK, Marsh J, McGlothlin A, McQuilten Z, Morpeth SC, Paterson DL, Price DJ, Roberts JA, Robinson JO, van Hal SJ, Walls G, Webb SA, Whiteway L, Yahav D, Davis JS; Staphylococcus aureus Network Adaptive Platform (SNAP) Study Group. The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe. Clin Infect Dis. 2022 Nov 30;75(11):2027-2034. doi: 10.1093/cid/ciac476.

    PMID: 35717634BACKGROUND

Related Links

MeSH Terms

Conditions

Staphylococcal InfectionsBacteremia

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Todd C Lee, MD MPH FIDSA

    Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

  • Emily G McDonald, MD MSc

    Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

  • Matthew P Cheng, MD

    Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lina Petrella

CONTACT

514-934-1934lina.petrella@muhc.mcgill.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 14, 2021

Study Start

May 20, 2024

Primary Completion

April 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 17, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(5)