Oropharyngeal candidiasis in immunocompromised children: a randomized, multicenter study of orally administered fluconazole suspension versus nystatin. The Multicenter Fluconazole Study Group.
OBJECTIVE
To compare the efficacy, safety, and tolerance of fluconazole suspension versus nystatin in the treatment of oropharyngeal thrush in immunocompromised children.


METHODS
Multicenter, randomized, observer-masked trial.


METHODS
Thirty-two centers participated, including hospitals and ambulatory care clinics.


METHODS
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 < 0.001), and eradication of the organism cultured at entry occurred in 76% and 11% (p < 0.001), respectively. Gastrointestinal conditions developed in six patients who received fluconazole and in three who received nystatin; two fluconazole recipients were subsequently withdrawn from the study. Laboratory abnormalities occurred with equal frequency in both groups. Clinical relapse rates were similar in both groups 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 nystatin in the treatment of thrush in immunocompromised children. Both regimens were well tolerated.
Flynn
P M
PM
Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105-2794, USA.
Cunningham
C K
CK
Kerkering
T
T
San Jorge
A R
AR
Peters
V B
VB
Pitel
P A
PA
Harris
J
J
Gilbert
G
G
Castagnaro
L
L
Robinson
P
P
D000284:Administration, Oral; D000293:Adolescent; D002180:Candidiasis, Oral / Q000188:drug therapy* / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D015725:Fluconazole / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D015658:HIV Infections / Q000276:immunology; D006801:Humans; D016867:Immunocompromised Host; D007165:Immunosuppression Therapy / Q000009:adverse effects; D007223:Infant; D009369:Neoplasms / Q000276:immunology; D009761:Nystatin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D012008:Recurrence
D009761:Nystatin; D015725:Fluconazole