title: Oropharyngeal candidiasis in immunocompromised children: a randomized, multicenter study of orally administered fluconazole suspension versus nystatin. The Multicenter Fluconazole Study Group.
abstract: 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six patients who received fluconazole and in three who received nystatin; two fluconazole recipients were subsequently withdrawn from the study.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.
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105-2794, USA.
authors.forename: P M
authors.initials: PM
authors.lastname: Flynn
authors.forename: C K
authors.initials: CK
authors.lastname: Cunningham
authors.forename: T
authors.initials: T
authors.lastname: Kerkering
authors.forename: A R
authors.initials: AR
authors.lastname: San Jorge
authors.forename: V B
authors.initials: VB
authors.lastname: Peters
authors.forename: P A
authors.initials: PA
authors.lastname: Pitel
authors.forename: J
authors.initials: J
authors.lastname: Harris
authors.forename: G
authors.initials: G
authors.lastname: Gilbert
authors.forename: L
authors.initials: L
authors.lastname: Castagnaro
authors.forename: P
authors.initials: P
authors.lastname: Robinson
mesh_terms: 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
chemical_list: D009761:Nystatin; D015725:Fluconazole