Evidence map›Paper›PMID 33136159›Full record

Trial reportJournal of the Pediatric Infectious Diseases Society2021

A Randomized Trial of Caspofungin vs Triazoles Prophylaxis for Invasive Fungal Disease in Pediatric Allogeneic Hematopoietic Cell Transplant.

Christopher C Dvorak, Brian T Fisher, Adam J Esbenshade, Michael L Nieder, Sarah Alexander, William J Steinbach, Ha Dang, Doojduen Villaluna, Lu Chen, Micah Skeens and 2 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the Pediatric Infectious Diseases Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01503515 (A Phase III Open-Label Trial of Caspofungin vs. Azole Prophylaxis for Patients at High-Risk for Invasive Fungal Infections), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 22% of its field
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.

NCT01503515 phase3completednot on this map

A Phase III Open-Label Trial of Caspofungin vs. Azole Prophylaxis for Patients at High-Risk for Invasive Fungal Infections (IFI) Following Allogeneic Hematopoietic Cell Transplantation (HCT)

TypeinterventionalSponsorChildren's Oncology GroupRan2013 to 2021Enrolled292ConditionsFungal Infection, Hematopoietic and Lymphoid Cell NeoplasmArmsCaspofungin Acetate, Fluconazole, Laboratory Biomarker Analysis, Voriconazole
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Diagnostic and Therapeutic Challenge Caused byPathogens (Basel, Switzerland) · 2024
    Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. 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

12 authors at 10 institutions in 2 countries.

Christopher C DvorakDivision of Pediatric Allergy, Immunology and Bone Marrow Transplant, University of California San Francisco, San Francisco, California, USA.
Brian T FisherDivision of Pediatrics Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
Adam J EsbenshadeDivision of Pediatric Hematology and Oncology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Michael L NiederDivision of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center, Tampa, Florida, USA.
Sarah AlexanderDivision of Haematology Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada.
William J SteinbachDivision of Pediatric Infectious Diseases, Duke University, Durham, North Carolina, USA.
Ha DangDepartment of Preventive Medicine, University of Southern California, Los Angeles, California, USA.
Doojduen VillalunaChildren's Oncology Group, Monrovia, California, USA.
Lu ChenDivision of Biostatistics, City of Hope, Duarte, California, USA.
Micah SkeensDepartment of Hematology/Oncology, Nationwide Children's Hospital, Columbus, Ohio, USA.
Theoklis E ZaoutisDivision of Pediatrics Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
Lillian SungDivision of Haematology Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada.
Children's Hospital of Philadelphia · USHospital for Sick Children · CAChildren's Oncology Group · USCity of Hope · USDuke University · USMoffitt Cancer Center · USNationwide Children's Hospital · USUniversity of California, San Francisco · USUniversity of Southern California · USVanderbilt University Medical Center · US

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
Towards a preventive cancer vaccine for children with constitutional mismatch repair deficiencyUG1CA189955 · NCI · PUBLIC HEALTH INSTITUTE · PI BRAD H POLLOCK, Michael E. Roth · 2014 to 2026
$62.5M
Community Clinical Oncology Program Research BaseU10CA095861 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI POLLOCK, BRAD H · 2002 to 2013
$19.5M
NCI NIH HHS U10 CA095861NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899NCI NIH HHS UG1 CA189955
6 · The paper itself

Abstract

backgroundChildren and adolescents undergoing allogeneic hematopoietic cell transplantation (HCT) are at high risk for invasive fungal disease (IFD).

methodsThis multicenter, randomized, open-label trial planned to enroll 560 children and adolescents (3 months to <21 years) undergoing allogeneic HCT between April 2013 and September 2016. Eligible patients were randomly assigned to antifungal prophylaxis with caspofungin or a center-specific comparator triazole (fluconazole or voriconazole). Prophylaxis was administered from day 0 of HCT to day 42 or discharge. The primary outcome was proven or probable IFD at day 42 as adjudicated by blinded central review. Exploratory analysis stratified this evaluation by comparator triazole.

resultsA planned futility analysis demonstrated a low rate of IFD in the comparator triazole arm, so the trial was closed early. A total of 290 eligible patients, with a median age of 9.5 years (range 0.3-20.7), were randomized to caspofungin (n = 144) or a triazole (n = 146; fluconazole, n = 100; voriconazole, n = 46). The day 42 cumulative incidence of proven or probable IFD was 1.4% (95% confidence interval [CI], 0.3%-5.4%) in the caspofungin group vs 1.4% (95% CI, 0.4%-5.5%) in the triazole group (P = .99, log-rank test). When stratified by specific triazole, there was no significant difference in proven or probable IFD at day 42 between caspofungin vs fluconazole (1.0%, 95% CI, 0.1%-6.9%, P = .78) or caspofungin vs voriconazole (2.3%, 95% CI, 0.3%-15.1%, P = .69).

conclusionsIn pediatric HCT patients, prophylaxis with caspofungin did not significantly reduce the cumulative incidence of early proven or probable IFD compared with triazoles. Future efforts to decrease IFD-related morbidity and mortality should focus on later periods of risk.

trial registrationNCT01503515.

Indexed as

Hematopoietic Stem Cell TransplantationInvasive Fungal InfectionsMycosesAdolescentAdultAntifungal AgentsCaspofunginChildChild, PreschoolHumansInfantTriazolesYoung AdultAntifungal AgentsCaspofunginTriazolescaspofunginfluconazolepediatrictransplantvoriconazole

Identifiers

PMID33136159
PMCPMC8087143
OpenAlexW3094879633

What Socratic holds

Textmetadata
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 Socratic graph.