Fluconazole vs. amphotericin B for the treatment of neonatal fungal septicemia: a prospective randomized trial

Pediatr Infect Dis J. 1996 Dec;15(12):1107-12. doi: 10.1097/00006454-199612000-00011.


Objective: Fungal septicemia is a devastating disease in the neonate, especially in the low birth weight preterm infant who is especially vulnerable to disseminated fungal sepsis. The objective of this study was to compare the efficacy, safety and overall convenience of fluconazole vs. amphotericin B for the treatment of disseminated fungal sepsis in neonates.

Design: A prospective, randomized, collaborative study conducted at two South African neonatal units.

Subjects: Twenty-four infants with proven fungal septicemia were treated from June, 1992, to June, 1993. Twelve received fluconazole, 11 received amphotericin B and 1 was excluded. Assessment of hepatic, renal and hematologic functions were performed before, during and after treatment. The two groups were comparable at the time of enrollment into the study.

Results: Infants receiving amphotericin B had significantly higher values of total and direct bilirubin and alkaline phosphatase values at the end of treatment, while the fluconazole group showed a significant increase in the platelet count. The cumulative total numbers of days receiving intravenous therapy for the administration of antifungal drugs were 57 for the fluconazole group and 162 for the amphotericin group; no central lines were needed in the fluconazole group, whereas 3 babies given amphotericin B had central catheters for a cumulative total of 27 days. The case fatality rate was 33% in the fluconazole group and 45% in the amphotericin B group; there was still proof of fungal septicemia at the time of death in 1 patient given amphotericin B and 2 given fluconazole.

Conclusion: Fluconazole showed fewer side effects than amphotericin B and was more convenient to use.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Amphotericin B / administration & dosage
  • Amphotericin B / adverse effects
  • Amphotericin B / therapeutic use*
  • Antifungal Agents / administration & dosage
  • Antifungal Agents / adverse effects
  • Antifungal Agents / therapeutic use*
  • Developing Countries*
  • Drug Administration Schedule
  • Female
  • Fluconazole / administration & dosage
  • Fluconazole / therapeutic use*
  • Fungemia / diagnosis
  • Fungemia / drug therapy*
  • Fungemia / physiopathology
  • Humans
  • Infant, Newborn
  • Injections, Intravenous
  • Intensive Care Units, Neonatal
  • Male
  • Prospective Studies
  • South Africa
  • Survival Rate
  • Treatment Outcome


  • Antifungal Agents
  • Amphotericin B
  • Fluconazole