Evidence map›Paper›PMID 33558294›Full record

Trial reportAntimicrobial agents and chemotherapy2021

High-Dose Micafungin in Neonates and Young Infants with Invasive Candidiasis: Results of a Phase 2 Study.

Cinzia Auriti, Bianca M Goffredo, Maria P Ronchetti, Fiammetta Piersigilli, Sara Cairoli, Iliana Bersani, Andrea Dotta, Pietro Bagolan, Manjunath P Pai

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03421002 (Determination of Plasmatic and CSF Levels of High Doses of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 24% 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.

NCT03421002 phase2completednot on this map

Determination of Plasmatic and CSF Levels of High Doses of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis

TypeinterventionalSponsorAstellas Pharma Global Development, Inc.Ran2015 to 2018Enrolled35ConditionsCandidiasis, Systemic, Candida MeningitisArmsMicafungin
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 19 citations in OpenAlex.

  1. Severe Congenital Candidiasis due toCase reports in pediatrics · 2026
    Article
  2. CongenitalAntibiotics (Basel, Switzerland) · 2025
    Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. InvasivePathogens (Basel, Switzerland) · 2021
    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

9 authors at 2 institutions in 2 countries.

Cinzia AuritiNeonatal Intensive Care Unit, Bambino Gesù Children's Hospital, Rome, Italy cinzia.auriti@opbg.net.ORCID 0000-0001-9820-6557
Bianca M GoffredoBiochemistry Laboratory, Department of Specialist Pediatrics, Bambino Gesù Children's Hospital, Rome, Italy.
Maria P RonchettiNeonatal Intensive Care Unit, Bambino Gesù Children's Hospital, Rome, Italy.
Fiammetta PiersigilliNeonatal Intensive Care Unit, Bambino Gesù Children's Hospital, Rome, Italy.
Sara CairoliBiochemistry Laboratory, Department of Specialist Pediatrics, Bambino Gesù Children's Hospital, Rome, Italy.
Iliana BersaniNeonatal Intensive Care Unit, Bambino Gesù Children's Hospital, Rome, Italy.
Andrea DottaNeonatal Intensive Care Unit, Bambino Gesù Children's Hospital, Rome, Italy.
Pietro BagolanNeonatal Surgical Unit, Bambino Gesù Children's Hospital, Rome, Italy.
Manjunath P PaiDepartment of Clinical Pharmacy, College of Pharmacy, University of Michigan, Ann Arbor, Michigan, USA.ORCID 0000-0001-7119-5034
Bambino Gesù Children's Hospital · ITUniversity of Michigan · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Limited data are available on the most appropriate dosing, efficacy, and safety of micafungin in neonates and young infants with invasive candidiasis (IC). This study evaluated plasma levels, efficacy, and safety of micafungin at a dose of 8 mg/kg daily for a mean of 13.3 days (±5.2 days) in 35 neonates and young infants with IC. Micafungin plasma concentrations were 5.70 mg/liter preadministration and 17.23, 15.59, and 10.27 mg/liter after 1, 2, and 8 h, respectively. The resolution of the infection was achieved in 86.7% of patients treated for ≥14 days. In 20.0% of patients, we observed a transient hypertransaminasemia. Micafungin at a dose of 8 mg/kg daily is effective and well tolerated in neonates and young infants with IC. (This study has been registered at ClinicalTrials.gov under identifier NCT03421002 and in the EU Clinical Trials Register under number 2014-003087-20.).

Indexed as

Candidiasis, InvasiveEchinocandinsAntifungal AgentsHumansInfantInfant, NewbornLipopeptidesMicafunginAntifungal AgentsEchinocandinsLipopeptidesMicafunginechinocandinsinvasive candidiasismicafunginneonatal intensive care unit

Identifiers

PMID33558294
PMCPMC8097467
OpenAlexW3126955629

What OpenQuestion holds

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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.