Published online July 31, 2006
PEDIATRICS Vol. 118 No. 3 September 2006, pp. e561-e569 (doi:10.1542/peds.2005-2033)
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ARTICLE

Topical Ciprofloxacin/Dexamethasone Superior to Oral Amoxicillin/Clavulanic Acid in Acute Otitis Media With Otorrhea Through Tympanostomy Tubes

Joseph Dohar, MDa, William Giles, MDb, Peter Roland, MDc, Nadim Bikhazi, MDd, Sean Carroll, DOe, Roderick Moe, MDf, Bradley Reese, MDg, Sheryl Dupre, MSh, Michael Wall, PhDh, David Stroman, PhDh, Celeste McLean, BSh and Krista Crenshaw, MSh

a Department of Otolaryngology, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania;
b CENTA Medical Group, Columbia, South Carolina
c Department of Otolaryngology, University of Texas Southwestern Medical Center, Dallas, Texas
d Ogden Clinic, Ogden, Utah
e ENT Specialists of NW Pennsylvania, Erie, Pennsylvania
f Pediatric ENT Institute of South Texas, San Antonio, Texas
g Florida Otolaryngology Group, Orlando, Florida
h Alcon Research, Ltd, Fort Worth, Texas

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 ≤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.

Key Words: otitis media • tympanostomy tubes • ciprofloxacin • dexamethasone • oral antibiotics

Abbreviations: CDC—Centers for Disease Control and Prevention • AOM—acute otitis media • AOMT—acute otitis media with otorrhea through tympanostomy tubes • TT—tympanostomy tube • FDA—US Food and Drug Administration • CIP/DEX—ciprofloxacin/dexamethasone otic suspension • AMOX/CLAV—amoxicillin/clavulanic acid suspension • TOC—test-of-cure • ITT—intent-to-treat • MITT—modified intent-to-treat

Accepted Mar 2, 2006.




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