Staphylococcus Aureus Bacteremia / Ertapenem / Staphylococcal Sepsis · Phase 2 Trial

Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia

ClinicalTrials.gov · September 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 randomized controlled trial comparing cefazolin plus ertapenem versus cefazolin plus placebo in methicillin-susceptible S. aureus bacteremia, currently recruiting and not yet reporting results. The trial is designed to test a mechanistic hypothesis derived from preclinical and case series data, with clinical success at Day 5 as the primary endpoint.

What was studied

Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia, Staphylococcal Sepsis, Staphylococcus Aureus Endocarditis; age from 18 Years; to 100 Years. Intervention: Ertapenem. Compared with: Placebo — Placebo Comparator. n = 60. 7 sites: Canada.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

Phase 2 RCT registered but not yet reporting results; addresses a mechanistic hypothesis from case series and animal data with no prior RCT evidence.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Clinical success (assessed at Day 5)

DesignPhase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationStaphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia, Staphylococcal Sepsis, Staphylococcus Aureus Endocarditis; age from 18 Years; to 100 Years

Sample size60

InterventionErtapenem

ComparatorPlacebo — Placebo Comparator

Setting7 sites: Canada

Reported figures

Quoted from the source exactly as published.

Planned enrollment60

PhasePhase 2

Primary outcome measureClinical success, Day 5

Caveats

This is a registry record only; no results are posted or available in this source.
Phase 2 design is exploratory and underpowered for practice-changing conclusions.
No prior RCT evidence exists; the hypothesis is based on in vitro, animal models, and case series only.
Study recruitment status is active; enrolment, follow-up duration, and analytical methods not detailed in this record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 randomized controlled trial within adaptive platform; appropriate for early efficacy signal.

Directness

strong

Tests clinical outcome (clinical success Day 5) in target population with bacteremia.

Consistency

insufficient

No prior RCT exists; evidence limited to in vitro, animal models, and case series.

Risk of bias

moderate

Placebo-controlled design appropriate; no information on blinding, allocation concealment, or conduct.

Sample adequacy

limited

Estimated 60 participants; underpowered for definitive safety or efficacy claims in Phase 2.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04886284). This is a study registration, not published results. Lead sponsor: Todd C. Lee MD MPH FIDSA. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia, Staphylococcal Sepsis, Staphylococcus Aureus Endocarditis. Interventions: DRUG: Ertapenem; DRUG: Placebo. Primary outcome measures: Clinical success , Day 5. 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)

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Todd C. Lee MD MPH FIDStaphylococcus Aureus BacteremiaErtapenemStaphylococcal SepsisStaphylococcus Aureus SepticemiaNCT04886284