Evidence map›Paper›PMID 39529079›Full record

Trial reportCritical care (London, England)2024

Length of hospital and intensive care unit stay in patients with invasive candidiasis and/or candidemia treated with rezafungin: a pooled analysis of two randomised controlled trials.

Patrick M Honoré, Matteo Bassetti, Oliver A Cornely, Herve Dupont, Jesús Fortún, Marin H Kollef, Peter Pappas, John Pullman, Jose Vazquez, Inga Bielicka and 4 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Critical care (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–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.

NCT02734862 phase2completednot on this map

A Phase 2, Multicenter, Randomized, Double-blind Study of the Safety, Tolerability, and Efficacy of Intravenous CD101 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)Ran2016 to 2019Enrolled207ConditionsCandidemia, Mycoses, Fungal Infection, FungemiaArmsCD101, Caspofungin, Fluconazole, intravenous placebo, oral placebo
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

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Brazilian guidelines for the diagnosis and treatment of candidemia and invasive candidiasis in adults and children.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
    Guideline
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Patrick M HonoréIntensive Care Department, CHU UCL Namur Godinne, UCL Louvain Medical School, 1, Avenue G Therasse, 5530, Yvoir, Belgium. Patrick.Honore@CHUUCLNamur.UClouvain.be.
Matteo BassettiDepartment of Health Sciences, University of Genoa, and Istituto Di Ricovero E Cura a Carattere, Ospedale Policlinico San Martino, Genoa, Italy.
Oliver A CornelyInstitute for Translational Research, University of Cologne, and Department I of Internal Medicine, Cologne, Germany.
Herve DupontAnesthesiology and Critical Care Medicine Department, University Hospital Amiens Picardie, Amiens, France.
Jesús FortúnRamón y Cajal University Hospital, CIBERINFEC, IRYCIS, Madrid, Spain.
Marin H KollefDivision of Pulmonary and Critical Care Medicine, Washington University, St Louis, MO, USA.
Peter PappasDivision of Infectious Diseases, Department of Internal Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
John PullmanClinical Research, Mercury Street Medical, Butte, MT, USA.
Jose VazquezDivision of Infectious Diseases, Department of Medicine, Medical College of Georgia/Augusta University, Augusta, GA, USA.
Inga BielickaMundipharma Research Ltd, Cambridge, UK.
Sara DickersonMundipharma Research Ltd, Cambridge, UK.
Nick ManamleyMundipharma Research Ltd, Cambridge, UK.
Taylor SandisonClinical Development, Cidara Therapeutics, Inc, San Diego, CA, USA.
George R ThompsonDivision of Infectious Diseases, Department of Internal Medicine, and Department of Medical Microbiology and Immunology, University of California Davis Medical Center, Sacramento, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInvasive candidiasis/candidemia (IC/C) is associated with a substantial health economic burden driven primarily by prolonged hospital stay. The once-weekly IV echinocandin, rezafungin acetate, has demonstrated non-inferiority to caspofungin in the treatment of IC/C. This paper reports a post hoc pooled exploratory analysis of length of stay (LoS) for hospital and intensive care unit (ICU) stays in two previously published clinical trials (ReSTORE [NCT03667690] and STRIVE [NCT02734862], that compared rezafungin with daily IV caspofungin (stable patients in the caspofungin group who met relevant criteria could step down to fluconazole after 3 days or more).

methodsLoS outcomes were analysed descriptively in the pooled modified intention to treat (mITT) population (all patients who had a documented Candida infection in line with trial requirements and received at least one dose of study drug). In addition, to adjust for an imbalance between treatment groups in the proportion receiving mechanical ventilation at baseline, a generalised linear model with mechanical ventilation as a binary covariate was applied. Responses to an exploratory question in the phase 3 trial on possible earlier discharge with weekly rezafungin are also reported.

results294 patients were included (rezafungin 139, caspofungin 155), of whom 126 (43%) had ICU admission. Patients treated with rezafungin had a numerically shorter LoS than with caspofungin in all analyses. Mean total LoS was 25.2 days, vs 28.3 days with caspofungin, and mean ICU LoS was 16.1 vs 21.6 days for rezafungin and caspofungin, respectively. After adjustment for mechanical ventilation status the difference in ICU LoS was 4.1 days, a relative difference of 24% (95% CI -11%, 72%). Physicians would have considered earlier discharge for 16% of patients (30/187) with weekly rezafungin, an average of 5-6 days earlier.

conclusionsRezafungin may enable shorter hospital and ICU LoS in IC/C compared with daily IV caspofungin, with accompanying savings in resource use. Further research is needed to confirm this in the real-world setting.

trial registrationNCT03667690 (ReSTORE; September 12, 2018); NCT02734862 (STRIVE; April 12, 2016).

Indexed as

Antifungal AgentsCandidemiaCandidiasis, InvasiveCaspofunginEchinocandinsIntensive Care UnitsLength of StayAdultAgedFemaleHumansMaleMiddle AgedAntifungal AgentsCaspofunginEchinocandinsRezafunginCandidemiaCaspofunginEchinocandinsInvasive candidiasisLength of hospital stayLength of ICU stayRezafungin

Identifiers

PMID39529079
PMCPMC11555819

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.