Original ArticleTwice Weekly Fluconazole Prophylaxis for Prevention of Invasive Candida Infection in High-risk Infants of <1000 Grams Birth Weight
Section snippets
Study Design
We conducted a prospective, randomized, double-blind clinical trial to evaluate the efficacy of twice weekly intravenous fluconazole prophylaxis to prevent Candida colonization and invasive infection. Twice weekly fluconazole prophylaxis was compared with the dosing schedule used in our previous study (Table I). Invasive Candida infection was defined as isolation of Candida species from the blood (venipuncture), urine (≥105 or more colony forming units/mL from sterile bladder catheterization or
Study Participants
Forty-one infants were randomized to Group A and 40 infants were randomized to Group B over the 24-month period between July 23, 2001, and July 4, 2003. Infants were born during the study period at our institution or transferred from another facility. Ninety-eight patients were born weighing <1000 grams. Nine of these patients did not require a central vascular catheter or endotracheal tube and thus were ineligible for study enrollment. A total of 89 infants met enrollment criteria during the
Discussion
This pilot study demonstrates that twice weekly dosing of fluconazole prophylaxis is similar in efficacy compared with the more frequent dosing of our earlier study in high-risk, preterm infants. The incidence of Candida colonization and invasive infection was similar for both regimens, and neither was associated with the emergence of resistant Candida or other fungal species. Twice weekly dosing, when compared with our previous study regimen, reduces the total number of fluconazole doses per
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