Randomized comparison of two nystatin oral gels with miconazole oral gel for treatment of oral thrush in infants. Antimycotics Study Group

Infection. 1996 Mar-Apr;24(2):136-9. doi: 10.1007/BF01713319.

Abstract

Recently, two commercial oral nystatin gels have been marketed in Germany (Candio-Hermal, Hermal; Lederlind, Lederle). In a prospective open randomized multicentre study involving 12 paediatricians in private practice, Candio-Hermal and Lederlind were compared with miconazole oral gel (Daktar, Janssen) in 95 infants with oral thrush (candidosis). Oral and rectal swabs were taken on days 0 and 14. Treatment duration varied according to the amount of drug contained in one tube (Candio-Hermal 10 days; Lederlind 14 days; Daktar 8 days). On day 14, clinical cure was observed in 23 of 27 infants treated with Daktar (85.1%), in 15 of 35 infants treated with Candio-Hermal (42.8%; p < 0.0007); and in 16 of 33 infants treated with Lederlind (48.5%; p < 0.004). Clinical relapses were observed in 15 patients (Candio-Hermal: n = 9; Lederlind: n = 6). The overall oral mycologic cure rate was significantly higher with Daktar (29.6%) and Candio-Hermal (20.0%) than with Lederlind (3.0%; p < 0.005 and < 0.03, respectively). It can be concluded that Daktar oral gel is significantly more effective than Candio-Hermal and Lederlind in curing oral thrush in infants.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Candidiasis, Oral / drug therapy*
  • Female
  • Gels / administration & dosage
  • Gels / therapeutic use
  • Humans
  • Infant
  • Male
  • Miconazole / administration & dosage
  • Miconazole / therapeutic use*
  • Nystatin / administration & dosage
  • Nystatin / therapeutic use*
  • Recurrence

Substances

  • Gels
  • Nystatin
  • Miconazole