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Candida - oral - Evidence
Evidence on antifungal drugs in young children and infants
CKS identified no placebo-controlled trials that unequivocally show the efficacy of antifungal drugs in the treatment of oral candidal infection in infants and young children. However, three comparative randomized controlled trials (RCTs) provide good evidence that topical miconazole and oral fluconazole are more effective than topical or oral nystatin for this purpose.
- An open-label RCT in 95 immunocompetent infants (2–17 months of age) with oral candidiasis, randomized them to receive one of two nystatin oral gel formulations or a miconazole oral gel formulation [Hoppe and Hahn, 1996].
- After 14 days of treatment, the clinical cure rate was 85.1% in the miconazole group, and significantly less in the two nystatin groups (42.8%, p < 0.0007, and 48.5%, p < 0.004 respectively).
- This means that for every two or three children treated with miconazole, an extra child would achieve clinical cure compared with nystatin (NNT 2–3).
- An open-label RCT in 227 immunocompetent infants (less than 1 year of age) randomized them to receive either miconazole oral gel (25 mg dose) or nystatin oral suspension (100,000 unit dose) for the treatment of oral thrush [Hoppe, 1997a].
- After 12 days, clinical cure was higher in the miconazole group (99%) than the nystatin group (54%, p < 0.0001, NNT 2).
- Miconazole was associated with an eradication rate (through microbiological testing) of 55.7%, compared with 13.0% for nystatin (p < 0.0001, NNT 3).
- Adverse effects (mainly gastrointestinal) were rare and similar for each group (4.5% for miconazole compared with 3.5% for nystatin).
- An open-label pilot RCT in 34 infants randomized them to receive oral suspensions of fluconazole or nystatin [Goins et al, 2002]. At the end of the treatment course (7 days for fluconazole and 10 days for nystatin):
- Clinical cure rate was significantly higher for children receiving fluconazole (100%) than nystatin (32%, p < 0.0001, NNT 2).
- Microbiological eradication was significantly higher for children receiving fluconazole (73%) than nystatin (6%, p < 0.0001, NNT 2).
- No adverse effects were reported in either group.
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