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Moraxella catarrhalis Infections
Haemophilus influenzae Infections
PEDIATRICS Vol. 113 No. 1 January 2004, pp. e40-e46

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, MD*, Leslie S. Kreisler, MD{ddagger}, Bradley Reese, MD§, Jack B. Anon, MD||, Brent Lanier, MD, Peter J. Conroy, PhD, JD#, G. Michael Wall, PhD#, Sheryl J. Dupre, BS#, Susan Potts, MS#, Gail Hogg, BS#, David W. Stroman, PhD# and Celeste McLean, BS#

* Department of Otolaryngology, University of Texas Southwestern Medical Center, Dallas, Texas
{ddagger} Virginia ENT Associates, Richmond, Virginia
§ Florida Otolaryngology Group, Orlando, Florida
|| ENT Specialists of Northwestern Pennsylvania, Erie, Pennsylvania
Central California ENT Medical Group, Fresno, California
# Alcon Research, Ltd, Fort Worth, Texas

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 ≥6 months to 12 years with an AOMT episode of ≤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.

Key Words: ciprofloxacin • dexamethasone • ofloxacin • otorrhea • AOM • tympanostomy tubes

Abbreviations: AOMT, acute otitis media with otorrhea through tympanostomy tubes • CSOM, chronic suppurative otitis media • TOC, test of cure • ITT, intention-to-treat

Received for publication Jan 14, 2003; Accepted Aug 26, 2003.




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