Gatifloxacin in the treatment of recurrent otitis media and otitis media treatment failure in children

Abstract

Gatifloxacin is a new fluoroquinolone with different properties, such as excellent activity against otitis media pathogens, less potential for selection of antimicrobial resistance, good middle ear penetration and a prolonged half life. Fluoroquinolone use in children has been limited owing to some concerns of arthrotoxicity based on observations made on juvenile animals. Nevertheless, multiple studies have been published showing that this observation, found only in certain animals, does not necessarily correlate to findings in humans. Results from four clinical (two Phase II and two Phase III) studies involving 1176 children have been published to evaluate the safety and efficacy of gatifloxacin (10 mg/kg once daily for 10 days) in children with complicated to treat otitis media. Three studies included a baseline tympanocentesis and one study included a mandatory, during therapy, tympanocentesis in those children with a positive baseline culture. In the double tympanocentesis study, the bacterial eradication rate was 90% (103/114). Among all clinically evaluated children treated with gatifloxacin, 90% (605/682) were considered to be a clinical success at the end of therapy and 90% by the end of the study. The overall incidence of gatifloxacin-related adverse events observed in the Phase III trials was 2% for both gatifloxacin and the comparator agent, amoxicillin-clavulanate. Among 453 gatifloxacin recipients, the incidence of adverse events was similar for children younger than 2 years old (16%) and older than 2 years (23%). Transitory arthralgia occurred in 1.4% (12/867) of gatifloxacin-treated children. At 1-year safety follow-up, data was collected among 77% of gatifloxacin-treated children and no evidence of arthropathy was reported.