Fusidic acid suspension twice daily: a new treatment schedule for skin and soft tissue infection in children, with improved tolerability.
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 b.i.d.) or a standard regimen (50 mg/kg divided t.i.d.), 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 b.i.d. dosage and for 194 (89.4%) of the 217 children given the standard t.i.d. 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 b.i.d. regimen and in 123 (99.2%) of the 124 children treated with the standard TID regimen.


CONCLUSIONS
The new twice-daily regimen had significantly better tolerance (p=0.025).
Török
Eva
E
Dermatology Department, Heim Pál Children's Hospital, Budapest, Hungary.
Somogyi
Tihamér
T
Rutkai
Krisztina
K
Iglesias
Luis
L
Bielsa
Isabel
I
D000284:Administration, Oral; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005672:Fusidic Acid / Q000008:administration & dosage*; D006801:Humans; D006814:Hungary; D007223:Infant; D008297:Male; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D017192:Skin Diseases, Bacterial / Q000188:drug therapy* / Q000473:pathology; D013030:Spain; D013207:Staphylococcal Skin Infections / Q000188:drug therapy / Q000473:pathology; D013290:Streptococcal Infections / Q000188:drug therapy / Q000473:pathology; D013535:Suspensions; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D013535:Suspensions; D005672:Fusidic Acid