Treatment of oropharyngeal candidiasis in immunocompetent infants: a randomized multicenter study of miconazole gel vs. nystatin suspension

Background. Miconazole gel has previously been shown to be an effective treatment for oropharyngeal candidiasis (thrush) in immunocompetent infants. This study compares miconazole gel with the standard therapeutic agent, nystatin suspension, with regard to efficacy, optimal duration of therapy and safety. Design. Prospective multicenter, randomized, office-based open trial. Patients. Twenty-six pediatricians enrolled 227 immunocompetent infants with signs of oropharyngeal thrush. Subjects were randomly assigned to receive 25 mg of miconazole as oral gel four times daily or 100 000 IU of nystatin as suspension four times daily after meals. All subjects were evaluated for safety. Fifteen patients whose thrush was not confirmed by culture were excluded from further analysis. The remaining 212 subjects were entered into an intention-totreat analysis. Another 29 patients violated the study protocol; the remaining 183 subjects were evaluated for efficacy (per protocol analysis). Results. Clinical cure by Day 5 of treatment was demonstrated in 84.7% of the 98 subjects in the miconazole group and 21.2% of the 85 subjects in the nystatin group (P < 0.0001). By Day 8, the cumulative clinical cure rates were 96.9% (miconazole) and 37.6% (nystatin), respectively (P < 0.0001). By Day 12, 99.0% of subjects in the miconazole group and 54.1% of subjects in the nystatin group were clinically cured (P < 0.0001). Premature cessation of treatment at parents' request because of lack of clinical efficacy occurred in none of the infants treated with miconazole and in 6 infants treated with nystatin (P = 0.029). The oral yeast eradication rate on Day 5 was 54.1% with miconazole and 8.2% with nystatin (P < 0.0001). Clinical relapses of oropharyngeal thrush and side effects of the study drugs were observed with similar frequency in both study arms. Conclusions. Miconazole gel was significantly superior to nystatin suspension with regard to efficacy, rapidity of achieving cure and oropharyngeal yeast eradication. Relapses and side effects did not occur more frequently with miconazole than with nystatin. The results of this study indicate that miconazole gel is superior to nystatin suspension as the treatment for oropharyngeal candidiasis in immunocompetent infants.