BACKGROUND: Recurrent otitis media and treatment failures of acute infections are refractory to therapy. Newer fluoroquinolones have excellent activity against respiratory pathogens, but their use in children has been limited because of concerns about adverse effects. METHODS: This was an open label, multicenter trial in which patients with recurrent otitis media or acute otitis media (AOM) treatment failure were treated with 10 mg/kg gatifloxacin oral suspension once daily for 10 days. Before treatment a tympanocentesis or a swab of middle ear fluid was obtained. Nasopharyngeal swabs were obtained at baseline and at the end of therapy. Efficacy was evaluated 3 to 10 days after cessation of treatment and at 3 to 4 weeks. Safety monitoring included special attention to any sign or symptom suggestive of joint or bone abnormality. RESULTS: The study enrolled 254 patients 6 months to 7 years of age, with one-half (52%) of the patients having recurrent otitis media, 17% having AOM treatment failure and 28% having both. Cure was achieved posttreatment in 88% of 198 clinically evaluable patients, with similar outcomes for patients younger or older than 2 years of age. Of the 45 evaluable patients with Streptococcus pneumoniae, 38 (84%) were cured, including 25 of 28 with penicillin-nonsusceptible strains. Also cured were 89% of those with Haemophilus influenzae and those with Moraxella catarrhalis. No selection of resistance to gatifloxacin was detected among nasopharyngeal pathogens. Eighty-three percent of the children had sustained cure at the 4 weeks follow-up visit. Adverse events were primarily mild gastrointestinal, with no occurrences of arthropathy. CONCLUSION: Gatifloxacin is safe and effective for treatment of recurrent otitis media and AOM treatment failure in children.
BACKGROUND: Recurrent otitis media and treatment failures of acute infections are refractory to therapy. Newer fluoroquinolones have excellent activity against respiratory pathogens, but their use in children has been limited because of concerns about adverse effects. METHODS: This was an open label, multicenter trial in which patients with recurrent otitis media or acute otitis media (AOM) treatment failure were treated with 10 mg/kg gatifloxacin oral suspension once daily for 10 days. Before treatment a tympanocentesis or a swab of middle ear fluid was obtained. Nasopharyngeal swabs were obtained at baseline and at the end of therapy. Efficacy was evaluated 3 to 10 days after cessation of treatment and at 3 to 4 weeks. Safety monitoring included special attention to any sign or symptom suggestive of joint or bone abnormality. RESULTS: The study enrolled 254 patients 6 months to 7 years of age, with one-half (52%) of the patients having recurrent otitis media, 17% having AOM treatment failure and 28% having both. Cure was achieved posttreatment in 88% of 198 clinically evaluable patients, with similar outcomes for patients younger or older than 2 years of age. Of the 45 evaluable patients with Streptococcus pneumoniae, 38 (84%) were cured, including 25 of 28 with penicillin-nonsusceptible strains. Also cured were 89% of those with Haemophilus influenzae and those with Moraxella catarrhalis. No selection of resistance to gatifloxacin was detected among nasopharyngeal pathogens. Eighty-three percent of the children had sustained cure at the 4 weeks follow-up visit. Adverse events were primarily mild gastrointestinal, with no occurrences of arthropathy. CONCLUSION:Gatifloxacin is safe and effective for treatment of recurrent otitis media and AOM treatment failure in children.
Authors: Christopher M Rubino; Edmund V Capparelli; John S Bradley; Jeffrey L Blumer; Gregory L Kearns; Michael Reed; Richard F Jacobs; Brenda Cirincione; Dennis M Grasela Journal: Antimicrob Agents Chemother Date: 2007-01-12 Impact factor: 5.191
Authors: Todd A Davies; Eugene Leibovitz; Gary J Noel; David F McNeeley; Karen Bush; Ron Dagan Journal: Antimicrob Agents Chemother Date: 2007-11-12 Impact factor: 5.191
Authors: Jason M Sansone; Norman J Wilsman; Ellen M Leiferman; James Conway; Paul Hutson; Kenneth J Noonan Journal: J Pediatr Orthop Date: 2009-03 Impact factor: 2.324
Authors: Miguel W Tregnaghi; Xavier Sáez-Llorens; Pio López; Hector Abate; Enrique Smith; Adriana Pósleman; Arlene Calvo; Digna Wong; Carlos Cortes-Barbosa; Ana Ceballos; Marcelo Tregnaghi; Alexandra Sierra; Mirna Rodriguez; Marisol Troitiño; Carlos Carabajal; Andrea Falaschi; Ana Leandro; Maria Mercedes Castrejón; Alejandro Lepetic; Patricia Lommel; William P Hausdorff; Dorota Borys; Javier Ruiz Guiñazú; Eduardo Ortega-Barría; Juan P Yarzábal; Lode Schuerman Journal: PLoS Med Date: 2014-06-03 Impact factor: 11.069