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

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.

RCT Entities:   Population Interventions Outcomes