Oropharyngeal candidiasis in immunocompromised children: A randomized, multicenter study of orally administered fluconazole suspension versus nystatin

• Published in: The Journal of pediatrics 1995-08, Vol.127 (2), p.322-328
• Main Authors: Flynn, Patricia M., Cunningham, Coleen K., Kerkering, Thomas, San Jorge, Antonia R., Peters, Vicki B., Pitel, Paul A., Harris, JoAnn, Gilbert, Gene, Castagnaro, Lee, Robinson, Patrick
• Format: Article
• Language: English
• Subjects: Biological and medical sciences; Immunodeficiencies; Immunodeficiencies. Immunoglobulinopathies; Immunopathology; Medical sciences
• ISSN: 0022-3476; 1097-6833
• DOI: 10.1016/S0022-3476(95)70321-7

Objective: To compare the efficacy, safety, and tolerance of fluconazole suspension versus nystatin in the treatment of oropharyngeal thrush in immunocompromised children. Design: Multicenter, randomized, observer-masked trial. Setting: Thirty-two centers participated, including hospitals and ambulatory care clinics. Patients: We enrolled 182 immunocompromised infants and children, ages 5 months to 14 years, with signs of oral thrush and presence of yeasts on potassium hydroxide– or gram-stained preparations. Subjects were randomly assigned to receive a single daily dose of fluconazole suspension, 2 to 3 mg/kg per day, or nystatin, 400,000 units four times daily for 14 days; 159 patients, who had culture confirmation of thrush and received at least 7 days of study drug, were evaluated for efficacy; all patients were evaluated for safety. Results: Clinical cure was demonstrated in 91% of the subjects in the fluconazole group and 51% of the subjects in the nystatin group ( p