Multicenter controlled trial comparing ceftibuten with @entity115 / XXXX in the empiric treatment of @entity697 media. Members of the Ceftibuten Otitis Media United States Study Group.

@entity1 @entity697 @entity115 @entity798 @entity10188 @entity2346
The efficacy and safety of ceftibuten (9 mg/kg daily for 10 days) were compared with those of @entity115 / @entity798 ( @entity10188 40 mg/kg/day given every 8 hours for 10 days) in the empiric treatment of @entity697 media in @entity1 . This was a multicenter, investigator-blinded study with 1:1 randomization. Overall clinical response and signs and symptoms of @entity2346 were collected prospectively pretreatment, 3 to 5 days during treatment, 1 to 3 days post-treatment and at 2- to 4-week follow-up. In addition to spontaneous reports of other adverse events, gastrointestinal adverse events were prospectively elicited at each visit. Two hundred ninety-six @entity1 (146 ceftibuten and 150 @entity115 / @entity798 ) were treated with at least 1 dose of study medication. Compliance with dosing was assessable with weight of drug consumed in 127 @entity1 in each treatment group. Five percent (6 of 127) of ceftibuten @entity1 and 11% (14 of 127) of @entity115 / @entity798 @entity1 received < 80% of prescribed drug (P = 0.10) and were therefore not valid. Two hundred twenty-two @entity1 (121 ceftibuten and 101 @entity115 / @entity798 ) received a minimum of 80% of prescribed medication and were compliant with the protocol. Ceftibuten and @entity115 / @entity798 groups were comparable both for demographic variables and for baseline signs and symptoms.(ABSTRACT TRUNCATED AT 250 WORDS)
