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, MD^a, William Giles, MD^b, Peter Roland, MD^c, Nadim Bikhazi, MD^d, Sean Carroll, DO^e, Roderick Moe, MD^f, Bradley Reese, MD^g, Sheryl Dupre, MS^h, Michael Wall, PhD^h, David Stroman, PhD^h, Celeste McLean, BS^h and Krista Crenshaw, MS^h

^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.

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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

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Accepted Mar 2, 2006.

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