Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes.

Peter S. Roland, Leslie S. Kreisler, Bradley Reese, Jack B. Anon, Brent Lanier, Peter J. Conroy, G. Michael Wall, Sheryl J. Dupre, Susan Potts, Gail Hogg, David W. Stroman, Celeste McLean

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Abstract

OBJECTIVE: To determine the efficacy and safety of topical ciprofloxacin/dexamethasone otic suspension compared with ofloxacin otic solution in the treatment of acute otitis media with otorrhea through tympanostomy tubes (AOMT) in pediatric patients. METHODS: This multicenter, prospective, randomized, observer-masked, parallel-group study was conducted at 39 sites in 599 children aged >or=6 months to 12 years with an AOMT episode of <or=3 weeks' duration. The mean age of patients was 2.5 years (standard deviation: 2.37 years). Patients received either ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension 4 drops twice daily for 7 days or ofloxacin 0.3% otic solution 5 drops twice daily for 10 days. Clinical signs and symptoms of AOMT were evaluated at clinic visits on days 1 (baseline), 3 (on therapy), 11 (end of therapy), and 18 (test of cure). A patient diary was used to measure time to cessation of otorrhea. Principal pretherapy pathogens included Streptococcus pneumoniae (16.8%), Staphylococcus aureus (13.0%), Pseudomonas aeruginosa (12.7%), Haemophilus influenzae (12.4%), S epidermidis (10.2%), and Moraxella catarrhalis (4.1%). RESULTS: Ciprofloxacin/dexamethasone is superior to ofloxacin for clinical cure (90% vs 78%) and microbiologic success (92% vs 81.8%) at the test-of-cure visit, produces fewer treatment failures (4.4% vs 14.1%), and results in a shorter median time to cessation of otorrhea (4 days vs 6 days). Ciprofloxacin/dexamethasone treatment is also superior to improvement in clinical response by visit, absence of otorrhea by visit, and reduction of otorrhea volume by visit. Both topical otic preparations are safe and well tolerated in pediatric patients. No change in speech recognition threshold or decrease in hearing from baseline, based on audiometric testing, was noted with either regimen. CONCLUSION: Topical ciprofloxacin/dexamethasone treatment is superior to topical ofloxacin in the treatment of AOMT.

Original languageEnglish (US)
JournalPediatrics
Volume113
Issue number1 Pt 1
StatePublished - Jan 2004

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Middle Ear Ventilation
Ofloxacin
Otitis Media
Ciprofloxacin
Dexamethasone
Ear
Suspensions
Therapeutics
Pediatrics
Moraxella (Branhamella) catarrhalis
Haemophilus influenzae
Ambulatory Care
Streptococcus pneumoniae
Treatment Failure
Pseudomonas aeruginosa
Hearing
Signs and Symptoms
Staphylococcus aureus
Safety

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes. / Roland, Peter S.; Kreisler, Leslie S.; Reese, Bradley; Anon, Jack B.; Lanier, Brent; Conroy, Peter J.; Wall, G. Michael; Dupre, Sheryl J.; Potts, Susan; Hogg, Gail; Stroman, David W.; McLean, Celeste.

In: Pediatrics, Vol. 113, No. 1 Pt 1, 01.2004.

Research output: Contribution to journalArticle

Roland, PS, Kreisler, LS, Reese, B, Anon, JB, Lanier, B, Conroy, PJ, Wall, GM, Dupre, SJ, Potts, S, Hogg, G, Stroman, DW & McLean, C 2004, 'Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes.', Pediatrics, vol. 113, no. 1 Pt 1.
Roland, Peter S. ; Kreisler, Leslie S. ; Reese, Bradley ; Anon, Jack B. ; Lanier, Brent ; Conroy, Peter J. ; Wall, G. Michael ; Dupre, Sheryl J. ; Potts, Susan ; Hogg, Gail ; Stroman, David W. ; McLean, Celeste. / Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes. In: Pediatrics. 2004 ; Vol. 113, No. 1 Pt 1.
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