Evidence map›Paper›PMID 21968355›Full record

Trial reportAntimicrobial agents and chemotherapy2011

Comparison of pharmacokinetics and safety of voriconazole intravenous-to-oral switch in immunocompromised children and healthy adults.

Timothy A Driscoll, Lolie C Yu, Haydar Frangoul, Robert A Krance, Eneida Nemecek, Jeffrey Blumer, Antonio Arrieta, Michael L Graham, Scott M Bradfield, Alice Baruch and 1 more

Abstract readClinical TrialComparative Study
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing 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.

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

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

  1. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
    Guideline
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Review
  10. Article
  11. Therapeutic drug monitoring andTranslational pediatrics · 2022
    Article
  12. Combined Effect ofFrontiers in pediatrics · 2022
    Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. Review
  20. Pediatric Invasive Aspergillosis.Journal of fungi (Basel, Switzerland) · 2016
    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

11 authors.

Timothy A DriscollDepartment of Pediatrics and Duke Clinical Research Institute, Duke University, Durham, North Carolina 06340, USA.
Lolie C Yu
Haydar Frangoul
Robert A Krance
Eneida Nemecek
Jeffrey Blumer
Antonio Arrieta
Michael L Graham
Scott M Bradfield
Alice Baruch
Ping Liu

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Voriconazole pharmacokinetics are not well characterized in children despite prior studies. To assess the appropriate pediatric dosing, a study was conducted in 40 immunocompromised children aged 2 to <12 years to evaluate the pharmacokinetics and safety of voriconazole following intravenous (IV)-to-oral (PO) switch regimens based on a previous population pharmacokinetic modeling: 7 mg/kg IV every 12 h (q12h) and 200 mg PO q12h. Area under the curve over the 12-h dosing interval (AUC(0-12)) was calculated using the noncompartmental method and compared to that for adults receiving approved dosing regimens (6 → 4 mg/kg IV q12h, 200 mg PO q12h). On average, the AUC(0-12) in children receiving 7 mg/kg IV q12h on day 1 and at IV steady state were 7.85 and 21.4 μg · h/ml, respectively, and approximately 44% and 40% lower, respectively, than those for adults at 6 → 4 mg/kg IV q12h. Large intersubject variability was observed. At steady state during oral treatment (200 mg q12h), children had higher average exposure than adults, with much larger intersubject variability. The exposure achieved with oral dosing in children tended to decrease as weight and age increased. The most common treatment-related adverse events were transient elevated liver function tests. No clear threshold of voriconazole exposure was identified that would predict the occurrence of treatment-related hepatic events. Overall, voriconazole IV doses higher than 7 mg/kg are needed in children to closely match adult exposures, and a weight-based oral dose may be more appropriate for children than a fixed dose. Safety of voriconazole in children was consistent with the known safety profile of voriconazole.

Indexed as

Administration, OralAdolescentAdultAntifungal AgentsAryl Hydrocarbon HydroxylasesChildChild, PreschoolCytochrome P-450 CYP2C19Dose-Response Relationship, DrugFemaleGenotypeHumansImmunocompromised HostInfusions, IntravenousLiver Function TestsMaleAntifungal AgentsAryl Hydrocarbon HydroxylasesCYP2C19 protein, humanCytochrome P-450 CYP2C19PyrimidinesTriazolesVoriconazole

Identifiers

PMID21968355
PMCPMC3232783

What OpenQuestion holds

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Registered trials

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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.