Results from two phase III studies presented at the 43rd Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) [Chicago, US; September 2003] showed that a new paediatric oral suspension of the fluoroquinolone, gatifloxacin was as effective as a conventional paediatric amoxicillin/clavulanate formulation and a new high-dose amoxicillin/clavulanate formulation in treating acute otitis media in children. Fluoroquinolones are not normally used in children other than for life-threatening infections due to arthrotoxic effects seen in juvenile animals, but the significance of extrapolating such studies to humans has been questioned. The studies involved > 700 children aged between 6 months and 7 years who had recurrent acute otitis media or had failed treatment for acute otitis media. There were no significant differences in the efficacies of gatifloxacin and amoxicillin/clavulanate in the two studies. However, in the first study, gatifloxacin was more effective than high-dose amoxicillin/clavulanate in children over 2 years of age, and those who had bilateral infection or severe infections. In the second study, gatifloxacin was more effective than amoxicillin/clavulanate in younger patients, those with bilateral disease and patients with moderate or severe infections. Importantly, treatment with gatifloxacin did not result in arthrotoxicity up to one year following treatment in either study.