Multinational multicenter controlled trial comparing @entity13665 with cefaclor for the treatment of XXXX . Members of the @entity13665 Otitis Media International Study Group.

@entity1 @entity697 @entity5504 @entity13665 @entity281
A randomized, controlled, single blind clinical trial was conducted in @entity1 with @entity697 to evaluate the safety and efficacy of a 10-day course of therapy with @entity13665 9 mg/kg taken as a single daily dose, up to a maximum daily dose of 400 mg, compared with @entity5504 40 mg/kg/day in three divided doses, up to a maximum of 1 g/day. @entity1 were evaluated any time from 1 to 3 days after completion of therapy (posttreatment follow-up). A total of 154 @entity1 (106 @entity13665 , 48 cefaclor) were evaluable for efficacy. Clinical success as determined by resolution (cure) or improvement of signs and symptoms of @entity281 were seen in 89 and 88% of @entity1 treated with @entity13665 and cefaclor, respectively, at the posttreatment follow-up visit. At the extended follow-up visit (any time from 2 to 4 weeks after completion of therapy), clinical success was sustained in 88 and 82% of the @entity13665 -treated and cefaclor-treated @entity1 , respectively. A total of 391 @entity1 (264 @entity13665 , 127 cefaclor) were included in the safety analysis. Treatment-related adverse experiences occurred in 8% of @entity13665 -treated @entity1 and 14% of cefaclor-treated @entity1 . All were mild or moderate and the majority were gastrointestinal. There were no deaths or serious adverse events. The results of this study suggest that @entity13665 is an effective and well-tolerated alternative to other antibiotic therapies for the treatment of @entity1 with @entity697 .
