Roland, Peter S.;
Anon, Jack B.;
Moe, Richard D.;
Conroy, Peter J.;
Wall, G. Michael;
Dupre, Sheryl J.;
Krueger, Kimberly A.;
Potts, Susan;
Hogg, Gail;
Stroman, David W.
Topical Ciprofloxacin/Dexamethasone is Superior to Ciprofloxacin Alone in Pediatric Patients with Acute Otitis Media and Otorrhea through Tympanostomy Tubes
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Media type:
E-Article
Title:
Topical Ciprofloxacin/Dexamethasone is Superior to Ciprofloxacin Alone in Pediatric Patients with Acute Otitis Media and Otorrhea through Tympanostomy Tubes
Contributor:
Roland, Peter S.;
Anon, Jack B.;
Moe, Richard D.;
Conroy, Peter J.;
Wall, G. Michael;
Dupre, Sheryl J.;
Krueger, Kimberly A.;
Potts, Susan;
Hogg, Gail;
Stroman, David W.
Description:
<jats:title>Abstract</jats:title><jats:p><jats:bold>Objective</jats:bold> To determine whether topical administration of a corticosteroid improves resolution of acute tympanostomy tube otorrhea when combined with topical antibiotic drops.</jats:p><jats:p><jats:bold>Study Design</jats:bold> Randomized, patient‐masked, parallel‐group, multicenter trial of topical otic ciprofloxacin/dexamethasone versus topical ciprofloxacin alone in 201 children aged 6 months to 12 years with acute otitis media with tympanostomy tubes (AOMT) of less than or equal to 3 weeks' duration and visible otorrhea.</jats:p><jats:p><jats:bold>Methods</jats:bold> Eligible patients were randomized to receive three drops of either ciprofloxacin 0.3%/dexamethasone 0.1% or ciprofloxacin 0.3% into the affected ear or ears twice daily for 7 days. Clinical signs and symptoms of AOMT were evaluated on days 1 (baseline), 3, 8 (end‐of‐therapy), and 14 (test‐of‐cure), and twice‐daily assessments of otorrhea were recorded in patient diaries.</jats:p><jats:p><jats:bold>Results</jats:bold> The mean time to cessation of otorrhea in the microbiologically culture‐positive patient population (<jats:italic>n</jats:italic> = 167) was significantly shorter with topical ciprofloxacin/dexamethasone than with ciprofloxacin alone (4.22 vs. 5.31 days; <jats:italic>P</jats:italic> = .004). This resulted in significantly better clinical responses on days 3 and 8 (<jats:italic>P</jats:italic> < .0001 and <jats:italic>P</jats:italic> = .0499, respectively). However, there were no significant differences between the two treatment groups in either the clinical response or the microbial eradication rate by day 14.</jats:p><jats:p><jats:bold>Conclusions</jats:bold> Topical otic treatment with ciprofloxacin/dexamethasone is superior to treatment with ciprofloxacin alone and results in a faster clinical resolution in children with AOMT. The contribution of the corticosteroid in achieving a 20% reduction (1.1 day) in time to cessation of otorrhea is clinically meaningful and represents an important advance over single‐agent antibiotic therapy.</jats:p>