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, Katherine Y. Berezny, Edmund Capparelli, Michael Cohen-Wolkowiez, Gregory L. Kearns, Matthew Laughon, Ian M. Paul, Michael J. Smith, John Van Den Anker, Kelly Wade, Fluconazole Prophylaxis Study Team on behalf of the Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committeea

Research output: Contribution to journalArticlepeer-review

36 Scopus citations


Background. Invasive 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. Methods. We 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. Results. Fluconazole 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. Conclusions. Fluconazole prophylaxis is effective and safe in reducing IC and Candida colonization in premature infants, and has no impact on resistance.

Original languageEnglish (US)
Pages (from-to)604-610
Number of pages7
JournalClinical infectious diseases : an official publication of the Infectious Diseases Society of America
Issue number5
StatePublished - Sep 1 2016


  • candidiasis
  • fluconazole
  • meta-analysis
  • premature infants

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases


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