Evidence map›Paper›PMID 27298330›Full record

SynthesisClinical infectious diseases : an official publication of the Infectious Diseases Society of America2016

Fluconazole Prophylaxis for the Prevention of Candidiasis in Premature Infants: A Meta-analysis Using Patient-level Data.

Jessica E Ericson, David A Kaufman, Stephen D Kicklighter, Jatinder Bhatia, Daniela Testoni, Jamie Gao, P Brian Smith, Kristi O Prather, Daniel K Benjamin, Fluconazole Prophylaxis Study Team on behalf of the Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committeea and 1 more

Open access · bronzeAbstract readMeta-Analysis
In one paragraph

Synthesis in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
4.2field-weighted citation impact, top 6% 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

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Pooled it
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  13. Observational
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  16. FatalJournal of fungi (Basel, Switzerland) · 2022
    Article
  17. Review
  18. Article
  19. Challenges in conducting paediatric trials with off-patent drugs.Contemporary clinical trials communications · 2021
    Article
  20. Review of Fluconazole Treatment and Prophylaxis for Invasive Candidiasis in Neonates.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 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

11 authors at 7 institutions in 2 countries.

Jessica E EricsonDepartment of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania.
David A KaufmanDepartment of Pediatrics, University of Virginia, Charlottesville.
Stephen D KicklighterWake Medical Center, Raleigh, North Carolina.
Jatinder BhatiaDepartment of Pediatrics, Georgia Regents University, Augusta.
Daniela TestoniEscola Paulista de Medicina, Universidade Federal de São Paulo, Brazil.
Jamie GaoDuke Clinical Research Institute.
P Brian SmithDuke Clinical Research Institute Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina.
Kristi O PratherDuke Clinical Research Institute.
Daniel K BenjaminDuke Clinical Research Institute Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina.
Fluconazole Prophylaxis Study Team on behalf of the Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committeea
Fluconazole Prophylaxis Study Team on behalf of the Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee
Clinical Research Institute · USDuke University · USGeorgia Regents Medical Center · USPenn State Milton S. Hershey Medical Center · USUniversidade Federal de São Paulo · BRUniversity of Virginia · USWake Research · US

Funding

Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
Increasing the Quality and Efficiency of Clinical Trials (R18)R18FD005292 · FDA · DUKE UNIVERSITY · PI LI, JENNIFER S · 2014 to 2019
$26.8M
Fungal biomarkers for diagnosis and response to therapy for pediatric candidemiaR01HD081044 · NICHD · DUKE UNIVERSITY · PI FISHER, BRIAN T, STEINBACH, WILLIAM J · 2014 to 2018
$3.2M
Mentorship of early-career pediatricians in quantitiative methods and therapeuticK24HD058735 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2009 to 2018
$1.5M
Institutional Training Grant in Pediatric Infectious DiseaseT32HD060558 · NICHD · DUKE UNIVERSITY · PI CUNNINGHAM, COLEEN K. · 2011 to 2015
$1.0M
FDA HHS R18 FD005292NCATS NIH HHS UL1 TR001117NIAID NIH HHS HHSN272201500006CNICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS K24 HD058735NICHD NIH HHS R01 HD081044NICHD NIH HHS T32 HD060558
6 · The paper itself

Abstract

backgroundInvasive candidiasis (IC) is an important cause of sepsis in premature infants and is associated with a high risk of death and neurodevelopmental impairment. Prevention of IC has become a major focus in very low birth weight infants, with fluconazole increasingly used as prophylaxis.

methodsWe identified all randomized, placebo-controlled trials evaluating fluconazole prophylaxis in premature infants conducted in the United States. We obtained patient-level data from the study investigators and performed an aggregated analysis. The occurrence of each endpoint in infants who received prophylaxis with fluconazole vs placebo was compared. Endpoints evaluated were IC or death, IC, death, Candida colonization, and fluconazole resistance among tested isolates. Safety endpoints evaluated included clinical and laboratory parameters.

resultsFluconazole prophylaxis reduced the odds of IC or death, IC, and Candida colonization during the drug exposure period compared with infants given placebo: odds ratios of 0.48 (95% confidence interval [CI], .30-.78), 0.20 (95% CI, .08-.51), and 0.28 (95% CI, .18-.41), respectively. The incidence of clinical and laboratory adverse events was similar for infants who received fluconazole compared with placebo. There was no statistically significant difference in the proportion of tested isolates that were resistant to fluconazole between the fluconazole and placebo groups.

conclusionsFluconazole prophylaxis is effective and safe in reducing IC and Candida colonization in premature infants, and has no impact on resistance.

Indexed as

Antibiotic ProphylaxisAntifungal AgentsFluconazoleInfant, PrematureCandidiasis, InvasiveFemaleHumansInfant, NewbornInfant, Newborn, DiseasesMaleRandomized Controlled Trials as TopicUnited StatesAntifungal AgentsFluconazolefluconazole; candidiasismeta-analysispremature infants

Identifiers

PMID27298330
PMCPMC4981761
OpenAlexW2435398593

What OpenQuestion holds

Textmetadata
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.