title: Open label, multicenter study of gatifloxacin treatment of recurrent otitis media and acute otitis media treatment failure.
abstract: 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.
  
  
  CONCLUSIONS
  Gatifloxacin is safe and effective for treatment of recurrent otitis media and AOM treatment failure in children.
authors: Hospital Nacional de Niños and Neeman-ICIC, Instituto de Atención Pediátrica, PO Box 6071-1150, San Jose, Costa Rica. aarguedas@uped.net
authors: Adriano
authors: A
authors: Arguedas
authors: Larry
authors: L
authors: Sher
authors: Eduardo
authors: E
authors: Lopez
authors: Xavier
authors: X
authors: Sáez-Llorens
authors: Kamal
authors: K
authors: Hamed
authors: Karen
authors: K
authors: Skuba
authors: Phillip F
authors: PF
authors: Pierce
mesh_terms: D000208:Acute Disease; D000284:Administration, Oral; D002648:Child; D002675:Child, Preschool; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage / Q000627:therapeutic use*; D000077734:Gatifloxacin; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000188:drug therapy* / Q000382:microbiology; D012008:Recurrence; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D024841:Fluoroquinolones; D000077734:Gatifloxacin