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RESEARCH SHOWS THAT LOWER DOSES OF ANTIFUNGAL DRUGS EFFECTIVE AT ELIMINATING RESISTANCE

Researchers at the University of Virginia Children’s Medical Center have found that lower doses of a popular anti-fungal treatment are just as effective at preventing fungal infections in newborns, while helping to avoid the problem of fungal resistance. The results will be presented at the annual conference of the Pediatric Academic Societies meeting in San Francisco, Calif., on Saturday, May 1.

Premature babies are often at risk for serious fungal infections that enter the blood stream and can become life threatening. In the search to prevent this risk, the principal investigators of the study, Dr. David Kaufman, assistant professor of pediatrics and Dr. Leigh Grossman, professor of pediatrics, both at the University of Virginia Children’s Medical Center, found that the drug fluconazole seems to stop fungal infections of the blood stream from developing. At the same time, Kaufman and his team of researchers were concerned that fungal resistance to fluconazole could emerge at the level of dosing they were using.

“When infants become infected, they often need to be intubated, have many additional blood draws, new intravenous lines placed, old intravenous lines removed, and additional days in the hospital,” Kaufman said. “Prevention of fungal infections will hopefully decrease the number of infants who die from this infection and reduce the need for additional invasive therapies, painful procedures, and long hospital stays.”

The researchers conducted a randomized, double-blind, clinical trial to evaluate the effectiveness of intravenous fluconazole given twice a week compared to the previous and more frequent dosing schedule. The study was conducted over a 24-month period in 81 high-risk preterm infants with the presence of an endotracheal tube or central venous catheter. The presence of tubes in newborns is a risk factor for the development of fungal infections in the blood stream.

Forty one infants were randomized to schedule A, and given doses of fluconazole every 3 days for the first 2 weeks, every other day during the third and fourth weeks, and every day during the fifth and sixth weeks. This was the most frequent dosing schedule. The other 40 infants were assigned to schedule B and given doses of fluconazole twice a week for 6 weeks.

The researchers found that Fluconazole given twice a week during the first 6 weeks is comparable to the prior dosing schedule in preventing fungal colonization and invasive infection in high-risk infants. This schedule decreases the costs of treatment and reduces patient drug exposure. The less frequent schedule for dosing also helps prevent antibiotic resistance, Kaufman said.

May 1, 2004