The Pharmaceutical Journal Vol 267 No 7178 p839-846
15 December 2001

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Fluconazole therapy prevents invasive fungal infection in preterm infants

Prophylactic administration of fluconazole is effective in preventing invasive fungal infection and fungal colonisation in preterm infants, a new study shows.

Researchers from the University of Virginia, Charlottesville, say that fungal infection accounts for 9 per cent of cases of late-onset sepsis in infants weighing less than 1.5kg and is associated with a mortality rate of 28 per cent, compared with 7 per cent among infants in whom no infection develops. Prophylaxis with fluconazole has been effective in reducing fungal colonisation and infection in immunocompromised patients, such as those undergoing bone marrow or solid-organ transplantation or those with leukaemia or human immunodeficiency virus, they say.

Dr David Kaufman and colleagues randomly assigned 100 preterm infants with birth weights of less than 1kg to receive fluconazole or placebo for six weeks, starting during their first five days of life. Fluconazole was administered intravenously at a dose of 3mg/kg of body weight every third day for the first two weeks, every other day during the third and fourth weeks and daily during the fifth and sixth weeks.

During the six-week treatment period, invasive fungal infection (shown as growth of fungi in cultures of blood, urine or cerebrospinal fluid) developed in 10 infants in the placebo group compared with none of the infants in the fluconazole group. Fungal colonisation was present at one or more sites (nasopharynx, skin, and stool or rectum) in 60 per cent of the infants in the placebo group compared with 22 per cent of those receiving fluconazole. The researchers say that fluconazole prophylaxis significantly reduced the incidence of Candida albicans colonisation overall, a finding consistent with previous data.

They add that fluconazole prevented invasive fungal disease and fungal colonisation without adverse effects or development of fluconazole resistance, which they attribute to the low total dose given and the intermittent dosing regimen.

The study is published in The New England Journal of Medicine (2001;345:1660).

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