title: Randomized, investigator-blinded, multicenter study of gatifloxacin versus amoxicillin/clavulanate treatment of recurrent and nonresponsive otitis media in children.
abstract: BACKGROUND
  Decreased susceptibility of pathogens to currently used agents for recurrent otitis media has provided the impetus for identifying new antimicrobial options.
  
  
  OBJECTIVE
  To compare gatifloxacin with amoxicillin/clavulanate in children with recurrent or nonresponsive acute otitis media (AOM).
  
  
  METHODS
  Included in this multicenter randomized trial were 413 patients, ranging in age from 6 months to 7 years, who had recurrent AOM (at least 3 episodes in the previous 6 months or 4 episodes in the previous 12 months) and/or had failed antibiotic therapy for AOM within 14 days of enrollment. Diagnosis required evidence of acute inflammation and otoscopic findings of middle ear effusion; baseline tympanocentesis was optional and encouraged. Children were randomly assigned (2:1) to 10 days of oral therapy with gatifloxacin suspension (10 mg/kg of body weight once daily) or amoxicillin/clavulanate suspension (45/6.4 mg/kg/d in 2 divided doses).
  
  
  RESULTS
  : Clinical cure was obtained in 90.2% (222 of 246) of patients in the gatifloxacin group and 84.3% (102 of 121) of those in the amoxicillin/clavulanate group (95% confidence interval, -1.9-12.9) 3-10 days after treatment ended. Gatifloxacin was associated with higher clinical cure rates than was amoxicillin/clavulanate in children younger than 2 years of age (92.0% versus 80.0%, respectively). Cure rates by pretreatment pathogen in the gatifloxacin and amoxicillin/clavulanate groups were 92.1% (35 of 38) versus 88.9% (16 of 18) for Streptococcus pneumoniae infections and 88.2% (30 of 34) versus 92.3% (12 of 13) for Haemophilus influenzae infections, respectively. Sustained clinical cures 3-4 weeks after treatment ended were obtained in 74.4% (183 of 246) of patients treated with gatifloxacin and 72.7% (88 of 121) of those treated with amoxicillin/clavulanate. Adverse events considered drug-related occurred with similar frequency in the 2 groups. Six patients (2.2%) in the gatifloxacin group and 2 patients (1.5%) in the amoxicillin/clavulanate group developed transient symptoms of mild or moderate arthralgia.
  
  
  CONCLUSIONS
  In this comparative evaluation of fluoroquinolone therapy in children with AOM, gatifloxacin was similar in clinical efficacy to amoxicillin/clavulanate 45/6.4 mg/kg/d for treatment of recurrent/nonresponsive infections.
authors.affiliation: Departamento de Infectologia, Hospital del Niño, Panama City, Panama.
authors.forename: Xavier
authors.initials: X
authors.lastname: Sáez-Llorens
authors.forename: Adib
authors.initials: A
authors.lastname: Rodriguez
authors.forename: Adriano
authors.initials: A
authors.lastname: Arguedas
authors.forename: Kamal A
authors.initials: KA
authors.lastname: Hamed
authors.forename: Joanna
authors.initials: J
authors.lastname: Yang
authors.forename: Phillip
authors.initials: P
authors.lastname: Pierce
authors.forename: Roger
authors.initials: R
authors.lastname: Echols
mesh_terms: D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage / Q000627:therapeutic use*; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077734:Gatifloxacin; D006192:Haemophilus Infections / Q000188:drug therapy / Q000382:microbiology; D006193:Haemophilus influenzae / Q000187:drug effects; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000188:drug therapy; D011008:Pneumococcal Infections / Q000188:drug therapy / Q000382:microbiology; D012008:Recurrence; D016037:Single-Blind Method; D013296:Streptococcus pneumoniae / Q000187:drug effects; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D019980:Amoxicillin-Potassium Clavulanate Combination; D000077734:Gatifloxacin