Evidence map›Paper›PMID 34031051›Full record

ArticleAntimicrobial agents and chemotherapy2021

Safety, Tolerability, and Population Pharmacokinetics of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients.

Antonio C Arrieta, Michael Neely, J Christopher Day, Susan R Rheingold, Paul K Sue, William J Muller, Lara A Danziger-Isakov, Julie Chu, Inci Yildirim, Grace A McComsey and 13 more

Open access · hybridAbstract read
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
6.5field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 56 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Real-life use of isavuconazole in Spanish children and adolescents.The Journal of antimicrobial chemotherapy · 2026
    Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Observational
  16. Isavuconazole use and TDM in real-world pediatric practice.Antimicrobial agents and chemotherapy · 2023
    Article
  17. Article
  18. Article
  19. Review
  20. Article
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

23 authors at 17 institutions in 2 countries.

Antonio C ArrietaChildren's Hospital of Orange County, Orange, California, USA.
Michael NeelyChildren's Hospital Los Angeles, University of Southern California, Los Angeles, California, USA.
J Christopher DayChildren's Mercy Kansas City, University of Missouri-Kansas City, Kansas City, Missouri, USA.
Susan R RheingoldChildren's Hospital of Philadelphia, Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Paul K SueUniversity of Texas Southwestern Medical Center, Dallas, Texas, USA.
William J MullerAnn & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.
Lara A Danziger-IsakovCincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Julie ChuChildren's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, USA.
Inci YildirimYale New Haven Children's Hospital, Yale School of Medicine, New Haven, Connecticut, USA.
Grace A McComseyUniversity Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
Haydar A FrangoulThe Children's Hospital at TriStar Centennial, Nashville, Tennessee, USA.
Tempe K ChenMemorialCare Miller Children's and Women's Hospital Long Beach, Long Beach, California, USA.
Victoria A StatlerNorton Children's and University of Louisville School of Medicine, Louisville, Kentucky, USA.
William J SteinbachDuke University Medical Center, Durham, North Carolina, USA.
Dwight E YinChildren's Mercy Kansas City, University of Missouri-Kansas City, Kansas City, Missouri, USA.
Kamal HamedBasilea Pharmaceutica International Ltd., Basel, Switzerland.
Mark E JonesBasilea Pharmaceutica International Ltd., Basel, Switzerland.
Christopher LademacherAstellas Pharma Global Development, Inc., Northbrook, Illinois, USA.
Amit DesaiAstellas Pharma Global Development, Inc., Northbrook, Illinois, USA.
Kelley MicklusAstellas Pharma Global Development, Inc., Northbrook, Illinois, USA.
Desiree Leiva PhillipsAstellas Pharma Global Development, Inc., Northbrook, Illinois, USA.
Laura L KovandaAstellas Pharma Global Development, Inc., Northbrook, Illinois, USA.
Thomas J WalshWeill Cornell Medicine, Cornell University, New York, New York, USA.
Astellas Pharma (United States) · USBasilea Pharmaceutica (Switzerland) · CHUniversity of Missouri–Kansas City · USChildren’s Hospital at TriStar Centennial · USChildren's Hospital of Orange County · USChildren's Hospital of Philadelphia · USChildren's Minnesota · USCincinnati Children's Hospital Medical Center · USCornell University · USDuke Medical Center · USLurie Children's Hospital · USMiller Children's & Women's Hospital · USThe University of Texas Southwestern Medical Center · USUniversity Hospitals of Cleveland · USUniversity of Louisville · USUniversity of Southern California · USYale New Haven Hospital · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

Isavuconazole, administered as the water-soluble prodrug isavuconazonium sulfate, is a new triazole agent used to treat invasive fungal infections. This phase 1 study evaluated the pharmacokinetics (PK), safety, and tolerability of isavuconazole in 46 immunocompromised pediatric patients, stratified by age (1 to <6 [intravenous (i.v.) only], 6 to <12, and 12 to <18 years), receiving 10 mg/kg body weight (maximum, 372 mg) isavuconazonium sulfate either i.v. or orally. A population PK model using weight-based allometric scaling was constructed with the pediatric i.v. and oral data plus i.v. data from a phase 1 study in adults. The best model was a 3-compartment model with combined zero-order and first-order input, with linear elimination. Stepwise covariate modeling was performed in Perl-speaks-NONMEM version 4.7.0. None of the covariates examined, including age, sex, race, and body mass index, were statistically significant for any of the PK parameters. The area under the concentration-time curve at steady state (AUC

Indexed as

Invasive Fungal InfectionsTriazolesAdministration, OralAdolescentChildChild, PreschoolHumansInfantNitrilesPyridinesisavuconazoleNitrilesPyridinesTriazolesinvasive fungal infectionsisavuconazolepediatricpopulation pharmacokineticstriazole

Identifiers

PMID34031051
PMCPMC8284446
OpenAlexW3165720081

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.