Researchers at the University of Virginia Health System found that an anti-fungal antibiotic successfully prevents serious fungal bloodstream infections in extremely premature infants, a patient group not previously treated with the drug. The findings appear in the December 6 edition of the New England Journal of Medicine.

"Fungal infection in premature infants is associated with very high mortality," said co-principal investigator Dr. David A. Kaufman, assistant professor of pediatrics, Division of Neonatology at U.Va. "We wanted to see if we could prevent this type of infection by giving premature infants the antifungal drug fluconazole."

For the randomized, controlled trial, Kaufman and co-principal investigator Dr. Leigh Grossman Donowitz, professor of pediatrics and chief of the Division of Infectious Diseases at U.Va., gave the drug to 100 premature infants born at 30 weeks or less of gestation and weighing less than two pounds. Half the babies received the medication for the first six weeks of life, the time when most of these babies are at extreme risk because of the life-saving treatments they require. The control subjects received a placebo medication. None of the babies receiving the medication got fungal infections, while 20 percent of those not receiving it developed serious fungal infections, Kaufman said.

"Fungal infections in premature babies is a marker of how sick they are," Donowitz said. "They receive many therapies, including steroids, antibiotics, surfactant drugs for underdeveloped lungs, ventilators and transfusions. All these things put them at risk for fungal infections."

Treating the premature infants with this antifungal therapy did not produce any of the side effects that may, in rare instances, occur with fluconazole use, such as liver damage, the researchers said. In addition, the fungi that were targeted did not develop resistance to the drug during this study.

"Resistance is a key issue and we followed it meticulously, which is one reason we think this study is important and the use of fluconazole safe for this indication," Kaufman said. "We followed it for each baby for the six weeks and we followed it in the unit over the 30-month study period, and significant resistance did not occur. This may be due to the lower dose and intermittent dosing we used and to the short, six-week period of exposure."

Donowitz and Kaufman hope to follow this pilot study with another that includes a larger number of patients, to more clearly determine if using this preventive therapy may not only decrease the risks for fungal infection but also may decrease the death rates of premature infants.

December 6, 2001

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