Evidence map›Paper›PMID 32032174›Full record

Trial reportThe Pediatric infectious disease journal2020

Safety, Efficacy and Pharmacokinetics of Anidulafungin in Patients 1 Month to <2 Years of Age With Invasive Candidiasis, Including Candidemia.

Emmanuel Roilides, Fabianne Carlesse, Margaret Tawadrous, Heidi Leister-Tebbe, Umberto Conte, Susan Raber, Robert Swanson, Jean L Yan, Jalal A Aram, Flavio Queiroz-Telles and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in The Pediatric infectious disease journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00761267 (A PROSPECTIVE, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY & EFFICACY OF ANIDULAFUNGIN WHEN USED TO TREAT CHILDREN WITH INVASIVE CANDIDIASIS, INCLUDING CANDIDEMIA), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

NCT00761267 phase3completednot on this map

A prospective, open-label study to assess the pharmacokinetics, safety & efficacy of anidulafungin when used to treat children with invasive candidiasis, including candidemia

TypeinterventionalSponsorPfizerRan2009 to 2018Enrolled70ConditionsCandidemiaArmsAnidulafungin, Fluconazole
3 · Its place in the literature

Who cites it

11 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. Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review on Current Status of Echinocandins Use.Antibiotics (Basel, Switzerland) · 2020
    Review
  11. Clinical and epidemiological aspects of Candidemia in eight medical centers in the state of Parana, Brazil: Parana Candidemia Network.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
    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

11 authors.

Emmanuel RoilidesFrom the Infectious Diseases Unit, 3 Department of Pediatrics, Faculty of Medicine, Aristotle University School of Health Sciences, Hippokration General Hospital, Thessaloniki, Greece.
Fabianne CarlesseInstitute of Pediatric Oncology (GRAACC), Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.
Margaret TawadrousGlobal Product Development, Pfizer Inc, Groton, Connecticut.
Heidi Leister-TebbePfizer Inc, New York, New York.
Umberto ContePfizer Inc, New York, New York.
Susan RaberPfizer Inc, New York, New York.
Robert SwansonPfizer Inc, New York, New York.
Jean L YanPfizer Inc, New York, New York.
Jalal A AramPfizer Inc, New York, New York.
Flavio Queiroz-TellesDepartment of Public Health, Universidade Federal do Paraná, Hospital de Clinicas, Curitiba, Paraná, Brazil.
Anidulafungin A8851008 Pediatric Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Nineteen patients 1 month to <2 years of age with (n = 16) or at high risk of (n = 3) invasive candidiasis received anidulafungin for 5-35 days (3 mg/kg day 1, 1.5 mg/kg daily thereafter) followed by optional fluconazole (NCT00761267). Most treatment-emergent adverse events were mild/moderate, and no treatment-related deaths occurred. End of intravenous therapy global response success rate was 68.8%. Pharmacokinetics were similar to adult patients.

Indexed as

Administration, IntravenousAnidulafunginAntifungal AgentsCandidemiaCandidiasis, InvasiveFemaleHumansInfantInfant, NewbornMaleProspective StudiesTreatment OutcomeAnidulafunginAntifungal Agents

Identifiers

PMID32032174
PMCPMC7182240

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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.