The treatment of systemic candidiasis in neonates with oral fluconazole.

Fungal septicaemia has become a frequent problem in neonatal intensive care units. The usual treatment for this condition, amphotericin B alone or in combination with 5-fluorocytosine, is sometimes unsatisfactory, especially in neonates. We report our experience of fluconazole in neonates. Neonates who developed Candida septicaemia in the neonatal unit of Ga-Rankuwa Hospital (MEDUNSA) over a 1-year period were treated with oral fluconazole. The diagnosis was based on fungal cultures obtained from sites which are normally sterile. Blood cultures and renal, haematological and liver functions were monitored regularly. Therapy was continued for at least 1 week after the first negative culture was obtained. Twenty-one neonates were treated; the clinical and microbiological cure rate was 90.5%. No serious renal, haematological or hepatic complications were detected; mild hepatotoxicity was evidenced by elevated enzymes in a third of the children. Relapse occurred in one baby who received inadequate doses of fluconazole. Two babies died of causes unrelated to a systemic fungal infection. We conclude that fluconazole may be a safe and effective alternative for the management of systemic candidiasis in neonates. A comparative trial is necessary.

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

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.