OROPHARYNGEAL CANDIDIASIS IN IMMUNOCOMPROMISED CHILDREN - A RANDOMIZED, MULTICENTER STUDY OF ORALLY-ADMINISTERED FLUCONAZOLE SUSPENSION VERSUS NYSTATIN

Objective: To compare the efficacy, safety, and tolerance of fluconazo le suspension versus nystatin in the treatment of oropharyngeal thrush in immunocompromised children. Design: Multicenter, randomized, obser ver-masked trial, Setting Thirty-two centers participated, including h ospitals and ambulatory care clinics, Patients: We enrolled 182 immuno compromised infants and children, ages 5 months to 14 years, with sign s of oral thrush and presence of yeasts on potassium hydroxide- or gra m-stained preparations, Subjects were randomly assigned to receive a s ingle daily dose of fluconazole suspension, 2 to 3 mg/kg per day, or n ystatin, 400,000 units four times daily for 14 days; 159 patients, who had culture confirmation of thrush and received at least 7 days of st udy drug, were evaluated for efficacy; all patients were evaluated for safety, Results: Clinical cure was demonstrated in 91% of the subject s in the fluconazole group and 51% of the subjects in the nystatin gro up (p <0.001), and eradication of the organism cultured at entry occur red in 76% and 11% (p <0.001), respectively. Gastrointestinal conditio ns developed in six patients who received fluconazole and in three who received nystatin; two fluconazole recipients were subsequently withd rawn from the study. Laboratory abnormalities occurred with equal freq uency in both groups. Clinical relapse rates were similar in both grou ps at 2 weeks (18% and 24% for fluconazole and nystatin, respectively) and 1 month (28% and 27%, respectively) after the completion of study drug. Conclusions: Fluconazole suspension is more effective than nyst atin in the treatment of thrush in immunocompromised children. Both re gimens were well tolerated.