Evidence map›Paper›PMID 19114680›Full record

Trial reportAntimicrobial agents and chemotherapy2009

Pharmacokinetics and safety of caspofungin in older infants and toddlers.

Michael Neely, Hasan S Jafri, Nita Seibel, Katherine Knapp, Peter C Adamson, Susan K Bradshaw, Kim M Strohmaier, Peng Sun, Sheng Bi, Marissa Fallon Dockendorf and 2 more

Registry-linked trialOpen access · greenAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00292071 (A Multicenter, Open, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of 2 Separate Doses of Caspofungin Acetate in Children Between the Ages of 3 to 24 Months With New Onset Fever and Neutropenia), which is not on this map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
5.2field-weighted citation impact, top 4% 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.

NCT00292071 phase2completednot on this map

A Multicenter, Open, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of 2 Separate Doses of Caspofungin Acetate in Children Between the Ages of 3 to 24 Months With New Onset Fever and Neutropenia

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2004 to 2006Enrolled16ConditionsFungal InfectionArmscaspofungin acetate
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 79 citations in OpenAlex.

  1. Pooled it
  2. Antifungal therapy in children: an update.European journal of pediatrics · 2013
    Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Invasive Aspergillosis in Children: Update on Current Guidelines.Mediterranean journal of hematology and infectious diseases · 2018
    Review
  9. Pediatric Invasive Aspergillosis.Journal of fungi (Basel, Switzerland) · 2016
    Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Breakthrough filamentous fungal infections in pediatric hematopoetic stem cell transplant and oncology patients receiving caspofungin.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2012
    Article
  19. Article
  20. 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 6 institutions in 1 country.

Michael NeelyChildren's Hospital, Los Angeles, California, USA.
Hasan S Jafri
Nita Seibel
Katherine Knapp
Peter C Adamson
Susan K Bradshaw
Kim M Strohmaier
Peng Sun
Sheng Bi
Marissa Fallon Dockendorf
Julie A Stone
Nicholas A Kartsonis
United States Military Academy · USChildren's Hospital of Los Angeles · USChildren's Hospital of Philadelphia · USChildren's National · USSt. Jude Children's Research Hospital · USThe University of Texas Southwestern Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Although information about the efficacy and safety experience with caspofungin at 50 mg/m(2) daily is available for children and adolescents, the dosing regimen in infants and toddlers 3 to 24 months of age has yet to be established. We studied the pharmacokinetics and safety of caspofungin at 50 mg/m(2) once daily in nine patients 10 to 22 months (median, 13 months) of age with fever and neutropenia who received caspofungin once daily for 2 to 21 (mean, 9.3) days. Plasma caspofungin concentrations were measured by high-performance liquid chromatography assay on days 1 and 4. On day 4, the area under the curve from 0 to 24 h (AUC(0-24)) was 130.3 microg-h/ml, the peak concentration (C(1)) was 17.2 microg/ml, and the trough concentration (C(24)) was 1.6 microg/ml. The day 4 geometric mean ratios (GMRs) and 90% confidence interval (CI) for these parameters in infants/toddlers relative to adults were 1.26 (1.06, 1.50), 1.83 (1.57, 2.14), and 0.81 (0.64, 1.04), respectively. Relative to children (2 to 11 years of age), the day 4 GMRs (and 90% CI) were 1.13 (0.89, 1.44), 1.10 (0.85, 1.42), and 1.12 (0.72, 1.76), respectively. The harmonic mean elimination phase t(1/2) in infants/toddlers (8.8 h) was reduced approximately 33% relative to adults (13.0 h) but was similar to that in children (8.2 h). Clinical adverse events occurred in seven patients (78%); none were considered drug related. Laboratory adverse events occurred in five patients (56%) and were considered drug related in three (33%). There were no infusion-related events or discontinuations due to toxicity. Caspofungin at 50 mg/m(2) daily was well tolerated in infants and toddlers; the AUC and caspofungin C(24) were generally comparable to those in adults receiving caspofungin at 50 mg daily.

Indexed as

Antifungal AgentsArea Under CurveCaspofunginEchinocandinsFemaleHumansInfantLipopeptidesMaleAntifungal AgentsCaspofunginEchinocandinsLipopeptides

Identifiers

PMID19114680
PMCPMC2663098
OpenAlexW2077408731

What OpenQuestion 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 OpenQuestion graph.