{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T08:58:22Z","timestamp":1792054702195,"version":"4.4.0"},"reference-count":15,"publisher":"American Academy of Pediatrics (AAP)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2006,9,1]]},"abstract":"<jats:p>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.<\/jats:p><jats:p>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 \u22643 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.<\/jats:p><jats:p>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 (&amp;gt;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%).<\/jats:p><jats:p>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.<\/jats:p>","DOI":"10.1542\/peds.2005-2033","type":"journal-article","created":{"date-parts":[[2006,8,2]],"date-time":"2006-08-02T07:47:16Z","timestamp":1154504836000},"page":"e561-e569","source":"Crossref","is-referenced-by-count":80,"title":["Topical Ciprofloxacin\/Dexamethasone Superior to Oral Amoxicillin\/Clavulanic Acid in Acute Otitis Media With Otorrhea Through Tympanostomy Tubes"],"prefix":"10.1542","volume":"118","author":[{"given":"Joseph","family":"Dohar","sequence":"first","affiliation":[{"name":"Department of Otolaryngology, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Giles","sequence":"additional","affiliation":[{"name":"CENTA Medical Group, Columbia, South Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Roland","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology, University of Texas Southwestern Medical Center, Dallas, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nadim","family":"Bikhazi","sequence":"additional","affiliation":[{"name":"Ogden Clinic, Ogden, Utah"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean","family":"Carroll","sequence":"additional","affiliation":[{"name":"ENT Specialists of NW Pennsylvania, Erie, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roderick","family":"Moe","sequence":"additional","affiliation":[{"name":"Pediatric ENT Institute of South Texas, San Antonio, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradley","family":"Reese","sequence":"additional","affiliation":[{"name":"Florida Otolaryngology Group, Orlando, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheryl","family":"Dupre","sequence":"additional","affiliation":[{"name":"Alcon Research, Ltd, Fort Worth, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Wall","sequence":"additional","affiliation":[{"name":"Alcon Research, Ltd, Fort Worth, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Stroman","sequence":"additional","affiliation":[{"name":"Alcon Research, Ltd, Fort Worth, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Celeste","family":"McLean","sequence":"additional","affiliation":[{"name":"Alcon Research, Ltd, Fort Worth, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krista","family":"Crenshaw","sequence":"additional","affiliation":[{"name":"Alcon Research, Ltd, Fort Worth, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[2006,9,1]]},"reference":[{"key":"2021120822530665800_R1","unstructured":"Centers for Disease Control and Prevention. 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