Lara Aguilar, Carolina Soley, A. Arguedas
Oct 16, 2007
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Journal
Pediatric Health
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 eradica...