title: Topical ciprofloxacin/dexamethasone superior to oral amoxicillin/clavulanic acid in acute otitis media with otorrhea through tympanostomy tubes.
abstract: OBJECTIVE
  This study was a comparison of topical ciprofloxacin/dexamethasone otic suspension to oral amoxicillin/clavulanic acid suspension in children with acute otitis media with otorrhea through tympanostomy tubes.
  
  
  METHODS
  This was a randomized, observer-masked, parallel-group, multicenter trial of topical ciprofloxacin/dexamethasone otic suspension versus amoxicillin/clavulanic acid suspension in 80 children aged 6 months to 12 years with acute otitis media with otorrhea through tympanostomy tubes of < or = 3 weeks' duration and visible otorrhea. Patients were randomly assigned to receive either 4 drops of topical ciprofloxacin 0.3%/dexamethasone 0.1% (Ciprodex Sterile Otic Suspension) into the affected ear(s) twice daily for 7 days or 600 mg of amoxicillin/42.9 mg of clavulanic acid oral suspension (Augmentin ES-600 Oral Suspension) every 12 hours for 10 days. Clinical signs and symptoms of acute otitis media with otorrhea through tympanostomy tubes were evaluated on days 1 (baseline), 3, 11 (end-of-therapy), and 18 (test-of-cure), and twice-daily assessments of otorrhea were recorded in patient diaries.
  
  
  RESULTS
  The median time to cessation of otorrhea was significantly shorter with ciprofloxacin/dexamethasone otic suspension than with amoxicillin/clavulanic acid suspension (4.0 vs 7.0 days; n = 79). This resulted in significantly more clinical cures at the test-of-cure visit (85% vs 59%, respectively). Frequent adverse events (> 3%) related to ciprofloxacin/dexamethasone otic suspension included ear pain (5.1%) and related to amoxicillin/clavulanic acid suspension included diarrhea (19.5%), dermatitis (7.3%), and gastroenteritis (4.9%).
  
  
  CONCLUSIONS
  Topical otic treatment with ciprofloxacin/dexamethasone otic suspension is superior to treatment with oral amoxicillin/clavulanic acid suspension and results in more clinical cures and earlier cessation of otorrhea with fewer adverse effects in children with acute otitis media with otorrhea through tympanostomy tubes.
authors.affiliation: Department of Otolaryngology, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Dohar
authors.forename: William
authors.initials: W
authors.lastname: Giles
authors.forename: Peter
authors.initials: P
authors.lastname: Roland
authors.forename: Nadim
authors.initials: N
authors.lastname: Bikhazi
authors.forename: Sean
authors.initials: S
authors.lastname: Carroll
authors.forename: Roderick
authors.initials: R
authors.lastname: Moe
authors.forename: Bradley
authors.initials: B
authors.lastname: Reese
authors.forename: Sheryl
authors.initials: S
authors.lastname: Dupre
authors.forename: Michael
authors.initials: M
authors.lastname: Wall
authors.forename: David
authors.initials: D
authors.lastname: Stroman
authors.forename: Celeste
authors.initials: C
authors.lastname: McLean
authors.forename: Krista
authors.initials: K
authors.lastname: Crenshaw
mesh_terms: D000208:Acute Disease; D000284:Administration, Oral; D000287:Administration, Topical; D000658:Amoxicillin / Q000008:administration & dosage* / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D002939:Ciprofloxacin / Q000008:administration & dosage* / Q000009:adverse effects; D019818:Clavulanic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010035:Otitis Media, Suppurative / Q000188:drug therapy*; D010406:Penicillins / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D000893:Anti-Inflammatory Agents; D010406:Penicillins; D019818:Clavulanic Acid; D002939:Ciprofloxacin; D003907:Dexamethasone; D000658:Amoxicillin