Evidence map›Paper›PMID 38985561›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

Treatment Outcomes Among Patients With a Positive Candida Culture Close to Randomization Receiving Rezafungin or Caspofungin in the ReSTORE Study.

Alex Soriano, Patrick M Honore, Oliver A Cornely, Methee Chayakulkeeree, Matteo Bassetti, Huang Haihui, Hervé Dupont, Young Keun Kim, Marin Kollef, Bart Jan Kullberg and 7 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03667690 (A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection vs. Intravenous Caspofungin Followed by Oral Fluconazole Step Down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT03667690 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection vs. Intravenous Caspofungin Followed by Oral Fluconazole Step Down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis

TypeinterventionalSponsorCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Ran2018 to 2021Enrolled199ConditionsCandidemia, Mycoses, Fungal Infection, Invasive CandidiasesArmsRezafungin for Injection, Caspofungin, Fluconazole, intravenous placebo, oral placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. ASP-COMPLEX: redefining antimicrobial stewardship to improve outcomes in high-risk patients with severe infections.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2026
    Review
  2. Article
  3. Early-Onset Candidemia in Adult Intensive Care Units.Diagnostics (Basel, Switzerland) · 2025
    Review
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

17 authors.

Alex SorianoHospital Clínic de Barcelona, IDIBAPS, University of Barcelona, Barcelona, Spain.ORCID 0000-0002-9374-0811
Patrick M HonoreCHU UCL Godinne Namur, UCL Louvain Medical School, Campus Godinne, Namur, Belgium.ORCID 0000-0002-6697-4890
Oliver A CornelyFaculty of Medicine Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Cologne, Germany.ORCID 0000-0001-9599-3137
Methee ChayakulkeereeDivision of Infectious Diseases and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.ORCID 0000-0002-4582-4914
Matteo BassettiInfectious Diseases Unit, IRCCS San Martino Polyclinic Hospital, Genoa, Italy.
Huang HaihuiInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.ORCID 0000-0003-3803-5877
Hervé DupontAmiens-Picardie University Hospital, Amiens, France.ORCID 0000-0002-5644-3412
Young Keun KimDepartment of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, South Korea.ORCID 0000-0002-2120-6265
Marin KollefWashington University, St. Louis, Missouri, USA.
Bart Jan KullbergRadboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0002-6813-8167
Nick ManamleyMundipharma Research Limited, Cambridge, United Kingdom.ORCID 0009-0003-9325-0323
Peter PappasUniversity of Alabama at Birmingham, Birmingham, Alabama, USA.
John PullmanMercury Street Medical, Butte, Montana, USA.
Taylor SandisonCidara Therapeutics, Inc., San Diego, California, USA.
Cecilia DignaniPSI-CRO, Durham, North Carolina, USA.ORCID 0000-0002-7446-6183
Jose A VazquezAugusta University, Augusta, Georgia, USA.ORCID 0000-0001-5774-819X
George R ThompsonUniversity of California Davis Medical Center, Sacramento, California, USA.ORCID 0000-0001-8518-5750

Funding

Cidara TherapeuticsMundipharma
6 · The paper itself

Abstract

backgroundRezafungin, a novel, once-weekly echinocandin for the treatment of candidemia and/or invasive candidiasis (IC) was noninferior to caspofungin for day 30 all-cause mortality (ACM) and day 14 global cure in the phase 3 ReSTORE trial (NCT03667690). We conducted preplanned subgroup analyses for patients with a positive culture close to randomization in ReSTORE.

methodsReSTORE was a multicenter, double-blind, double-dummy, randomized trial in patients aged ≥18 years with candidemia and/or IC treated with once-weekly intravenous rezafungin (400 mg/200 mg) or once-daily intravenous caspofungin (70 mg/50 mg). This analysis comprised patients with a positive blood culture drawn between 12 hours before and 72 hours after randomization or a positive culture from another normally sterile site sampled between 48 hours before and 72 hours after randomization. Efficacy endpoints included day 30 ACM, day 14 global cure rate, and day 5 and 14 mycological response. Adverse events were evaluated.

resultsThis analysis included 38 patients randomized to rezafungin and 46 to caspofungin. In the rezafungin and caspofungin groups, respectively, day 30 ACM was 26.3% and 21.7% (between-group difference [95% confidence interval], 4.6% [-13.7%, 23.5%]), day 14 global response was 55.3% and 50.0% (between-group difference, 5.3% [-16.1%, 26.0%]), and day 5 mycological eradication was 71.1% and 50.0% (between-group difference, 21.1% [-0.2%, 40.2%]). Safety was comparable between treatments.

conclusionsThese findings support the efficacy and safety of rezafungin compared with caspofungin for the treatment of candidemia and/or IC in patients with a positive culture close to randomization, with potential early treatment benefits for rezafungin.

Indexed as

Antifungal AgentsCandidaCandidemiaCaspofunginEchinocandinsAdultAgedCandidiasisCandidiasis, InvasiveDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeYoung AdultAntifungal AgentsCaspofunginEchinocandinsRezafungincandidemiacaspofunginechinocandininvasive candidiasisrezafungin

Identifiers

PMID38985561
PMCPMC11426279

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.