Evidence map›Paper›PMID 41194465›Full record

Trial reportMycoses2025

Efficacy and Safety of Rezafungin Versus Caspofungin for the Treatment of Candidemia and Invasive Candidiasis in a China Cohort of a Double-Blind, Randomised, Phase 3 Trial (ReSTORE China).

Haihui Huang, Sizhou Feng, Yunsong Yu, Yong Zhang, Yuan Yuan, Laura Cox, Yingyuan Zhang

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Mycoses, 2025. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Trial
  2. Trial
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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

7 authors.

Haihui HuangInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
Sizhou FengInstitute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.
Yunsong YuSir Run Run Shaw Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.ORCID https://orcid.org/0000-0003-2903-918X
Yong ZhangThe First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China.
Yuan YuanGansu Provincial Hospital, Lanzhou, Gansu, China.
Laura CoxMundipharma Research Ltd, Cambridge, UK.
Yingyuan ZhangInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.ORCID https://orcid.org/0000-0001-9564-2353

Funding

Mundipharma Research Limited
6 · The paper itself

Abstract

backgroundThe global double-blind, randomised, Phase 3 ReSTORE trial (NCT03667690) demonstrated noninferiority of rezafungin versus caspofungin for all-cause mortality at Day 30 and global cure at Day 14 in patients with candidemia and/or invasive candidiasis.

objectivesWe report outcomes for patients from China (ReSTORE China), comprising participants enrolled in the original ReSTORE trial (n = 11) and from an extended, China-only phase (n = 47) implemented to fulfill Chinese regulatory requirements.

methodsPatients with candidemia/invasive candidiasis were randomised 1:1 to intravenous rezafungin (400 mg loading, then 200 mg once weekly) or caspofungin (70 mg loading, then 50 mg once daily) for ≤ 4 weeks. Primary endpoints were all-cause mortality at Day 30 and global cure at Day 14 in the modified intent-to-treat population. Between October 2018 and March 2024, 58 patients were randomised and received study treatment (rezafungin n = 28 [modified intent-to-treat n = 27], caspofungin n = 30 [modified intent-to-treat n = 28]).

resultsAll-cause mortality at Day 30 was 33.3% (9/27) for rezafungin versus 35.7% (10/28) for caspofungin (difference -2.4% [95% confidence interval -27.0-22.6]). Global cure at Day 14 was 48.1% (13/27) versus 46.4% (13/28), respectively (weighted difference 0.3% [95% confidence interval -25.4-26.3]). Day 5 and 14 mycological eradication rates were 70.4% and 63.0% for rezafungin versus 71.4% and 67.9% for caspofungin, respectively. Safety and tolerability profiles were similar between groups.

conclusionsRezafungin demonstrated similar efficacy and safety to caspofungin in the ReSTORE China cohort. These findings support the primary ReSTORE analysis and suggest that rezafungin could provide a new treatment option for candidemia/invasive candidiasis in China.

trial registrationClinicalTrials.gov identifier: NCT03667690.

Indexed as

Antifungal AgentsCandidemiaCandidiasis, InvasiveCaspofunginEchinocandinsAdultAgedChinaDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeYoung AdultAntifungal AgentsCaspofunginEchinocandinsRezafunginantifungal agentscandidemiacaspofunginChinaechinocandinsinvasive candidiasisPhase 3 trialrezafungin

Identifiers

PMID41194465
PMCPMC12589930

What Socratic 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 Socratic graph.