Abstract
OBJECTIVE: This multicentre, randomized, double‐blind, parallel group study aimed to compare a new regimen of fusidic acid suspension against a standard regimen in children with skin and soft tissue infections.
METHODS: Treatment groups were given either a new regimen of fusidic acid suspension (20 mg/kg divided BID) or a standard regimen (50 mg/kg divided TID), which were administered for 5 days in both groups and for a further 5 days if evidence of infection persisted. Assessment of those cured was carried out 14 days.
RESULTS: Both regimens were effective. Cure was achieved in 194 (91.1%) of the 213 children given the new BID dosage and for 194 (89.4%) of the 217 children given the standard TID dosage (intention‐to‐treat population; p=0.72). Cure was maintained at the follow‐up assessment for 94.8% (181 of 191) and 95.7% (180 of 188), respectively, of the children. Bacteriological cure of infections due to fusidic acid susceptible Staphylococcus aureus and/or group A beta‐haemolytic streptococci, with elimination of pathogens, was achieved in all 121 (100%) children treated with the new BID regimen and in 123 (99.2%) of the 124 children treated with the standard TID regimen.
CONCLUSION: The new twice‐daily regimen had significantly better tolerance (p=0.025).