Evidence map›Paper›PMID 32271718›Full record

Trial reportThe Journal of clinical investigation2020

Exebacase for patients with Staphylococcus aureus bloodstream infection and endocarditis.

Vance G Fowler, Anita F Das, Joy Lipka-Diamond, Raymond Schuch, Roger Pomerantz, Luis Jáuregui-Peredo, Adam Bressler, David Evans, Gregory J Moran, Mark E Rupp and 5 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in The Journal of clinical investigation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03163446 (A Multicenter, Double-Blind, Randomized, Comparative Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of CF-301 vs. Placebo in Addition to Standard-of-Care Antibacterial Therapy for the Treatment of Adult Patients With Staphylococcus Aureus Bloodstream Infections), which is not on this map. Cited by 86 papers.

0numbers the graph read from it
0cells of the map it votes in
86citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03163446 phase2completednot on this map

A Multicenter, Double-Blind, Randomized, Comparative Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of CF-301 vs. Placebo in Addition to Standard-of-Care Antibacterial Therapy for the Treatment of Adult Patients With Staphylococcus Aureus Bloodstream Infections (Bacteremia) Including Endocarditis

TypeinterventionalSponsorContraFectRan2017 to 2019Enrolled121ConditionsStaphylococcus Aureus Bacteremia, Staphylococcus Aureus EndocarditisArmsCF-301, Placebo
3 · Its place in the literature

Who cites it

86 citing papers in PubMed.

  1. Review
  2. Article
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  5. Review
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  8. Review
  9. Review
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  11. Review
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  15. [Phage endolysins-a novel class of antibacterial agents with a wide range of applications].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2025
    Review
  16. Review
  17. Article
  18. Article
  19. Review
  20. Endolysins: targetingFrontiers in microbiology · 2025
    Review

26 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Vance G FowlerDuke University Medical Center, Durham, North Carolina, USA.
Anita F DasAD Stat Consulting, Guerneville, California, USA.
Joy Lipka-DiamondLipka Consulting, Mullica Hill, New Jersey, USA.
Raymond SchuchContraFect Corporation, Yonkers, New York, USA.
Roger PomerantzContraFect Corporation, Yonkers, New York, USA.
Luis Jáuregui-PeredoMercy Health-St. Vincent Medical Center, Toledo, Ohio, USA.
Adam BresslerInfectious Disease Specialists of Atlanta, Georgia, USA.
David EvansThe Ohio State University, Columbus, Ohio, USA.
Gregory J MoranOlive View-UCLA Medical Center, Sylmar, California, USA.
Mark E RuppUniversity of Nebraska Medical Center, Omaha, Nebraska, USA.
Robert WiseJohns Hopkins Bayview Medical Center, Baltimore, Maryland, USA.
G Ralph CoreyDuke University Medical Center, Durham, North Carolina, USA.
Marcus ZervosHenry Ford Health System, Detroit, Michigan, USA.
Pamela S DouglasDuke University Medical Center, Durham, North Carolina, USA.
Cara CassinoContraFect Corporation, Yonkers, New York, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUNDNovel therapeutic approaches are critically needed for Staphylococcus aureus bloodstream infections (BSIs), particularly for methicillin-resistant S. aureus (MRSA). Exebacase, a first-in-class antistaphylococcal lysin, is a direct lytic agent that is rapidly bacteriolytic, eradicates biofilms, and synergizes with antibiotics.METHODSIn this superiority-design study, we randomly assigned 121 patients with S. aureus BSI/endocarditis to receive a single dose of exebacase or placebo. All patients received standard-of-care antibiotics. The primary efficacy endpoint was clinical outcome (responder rate) on day 14.RESULTSClinical responder rates on day 14 were 70.4% and 60.0% in the exebacase + antibiotics and antibiotics-alone groups, respectively (difference = 10.4, 90% CI [-6.3, 27.2], P = 0.31), and were 42.8 percentage points higher in the prespecified exploratory MRSA subgroup (74.1% vs. 31.3%, difference = 42.8, 90% CI [14.3, 71.4], ad hoc P = 0.01). Rates of adverse events (AEs) were similar in both groups. No AEs of hypersensitivity to exebacase were reported. Thirty-day all-cause mortality rates were 9.7% and 12.8% in the exebacase + antibiotics and antibiotics-alone groups, respectively, with a notable difference in MRSA patients (3.7% vs. 25.0%, difference = -21.3, 90% CI [-45.1, 2.5], ad hoc P = 0.06). Among MRSA patients in the United States, median length of stay was 4 days shorter and 30-day hospital readmission rates were 48% lower in the exebacase-treated group compared with antibiotics alone.CONCLUSIONThis study establishes proof of concept for exebacase and direct lytic agents as potential therapeutics and supports conduct of a confirmatory study focused on exebacase to treat MRSA BSIs.TRIAL REGISTRATIONClinicaltrials.gov NCT03163446.FUNDINGContraFect Corporation.

Indexed as

Endocarditis, BacterialStaphylococcal InfectionsAdultDisease-Free SurvivalEndopeptidasesFemaleHumansMaleMethicillin-Resistant Staphylococcus aureusSurvival RateEndopeptidasesexebacaseBacterial infectionsClinical TrialsInfectious disease

Identifiers

PMID32271718
PMCPMC7324170

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.