An open, non-comparative, clinical prospective study was performed to evaluate the efficacy and tolerability of ceftibuten in the treatment of acute mild-otitis in adult and pediatric patients. The drug was administered at a dose of 400 mg/day in adults and 9 mg/kg/day in children in a single daily oral dose for 7 days. The series consisted of 47 outpatients, 39 adults and 8 children with a total of 50 ears which met the requisites for inclusion in the study. Patients were examined before, during and at the end of treatment, and after an interval of 7 days following the end of treatment. At each control scores were evaluated for the following parameters: symptoms of otalgia, hypoacusia and otorrhea and signs of hypermia, extroflexion, perforation of the tympanic membrane and presence of exudate in the external ear channel. The trend of signs and symptoms at the four controls was evaluated using statistical methods. After treatment it was found that 68% of ears had clinically resolved, 30% presented a significant improvement and treatment had failed in only 2%. Those patients showing significant improvement presented residual catarrhal otitis which was treated with a non-steroid anti-inflammatory drug. At the follow-up clinical resolution was reported in 87% of ears, a significant improvement in 11% and recidivation in only 2%. Gastrointestinal collateral effects were reported in 3 patients (diarrhea and nausea). The study confirmed the excellent reliability of ceftibuten as a first-choice antibiotic for the empiric treatment of acute mid-otitis and closed tympanum.
|Translated title of the contribution||Efficacy and tolerability of a new oral cephalosporin, ceftibuten, in the treatment of acute mid-otitis|
|Number of pages||6|
|Publication status||Published - 1995|
ASJC Scopus subject areas