Randomized, double-blind study of the clinical efficacy of 3 days of azithromycin compared with co-amoxiclav for the treatment of acute otitis media

Authors: Michael W. Dunne¹; Thomas Latiolais²; Barnett Lewis³; Bruce Pistorius⁴; Gerald Bottenfield⁵; William H. Moore⁶; Anne Garrett⁷; Tracy D. Stewart⁸; Jeffrey Aoki⁹; Craig Spiegel¹⁰; David Boettger¹¹; Anne Shemer¹²

Source: Journal of Antimicrobial Chemotherapy, Volume 52, Number 3, September 2003 , pp. 469-472(4)

Publisher: Oxford University Press

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Abstract:

Background: Compared with 5 days of dosing, a 3 day dosing regimen of azithromycin for treatment of acute otitis media (AOM) may improve compliance, will simplify therapy for the caregiver and, by giving the same total dose as the 5 day regimen, provide more drug when the bacterial burden is highest.

Methods: Children of 6 months–12 years were enrolled if they had had symptoms and signs of AOM for <4 weeks and tympanic membrane effusion by acoustic reflectometry. Eligible children were randomized to azithromycin 10 mg/kg/day × 3 days or co-amoxiclav 45 mg/kg/day × 10 days. The primary endpoint was clinical response at day 28.

Results: One hundred and eighty-eight children (mean age 3.5 years) were randomized to azithromycin and 185 to co-amoxiclav. At day 10, the clinical success rate was 153/185 (83%) in children treated with azithromycin and 159/181 (88%) in children treated with co-amoxiclav. At day 28, 134/182 (74%) of the children were cured on azithromycin compared with 124/180 (69%) on co-amoxiclav. Also at day 28, signs of AOM, such as abnormal reflectometry (45% versus 59%; P = 0.017), bulging of the eardrum (10% versus 16%; P = 0.059) and loss of tympanic membrane landmarks (11% versus 22%; P = 0.010) were seen less frequently in azithromycin- than co-amoxiclav-treated children, respectively. Adverse events related to therapy were seen in 11% of azithromycin patients compared with 20% on co-amoxiclav (P = 0.014).

Conclusions: Azithromycin given over 3 days is as effective as co-amoxiclav for treatment of AOM, may result in more complete resolution of tympanic membrane disease, and is better tolerated.

Keywords: children; AOM

Document Type: Research article

DOI: http://dx.doi.org/10.1093/jac/dkg358

Affiliations: 1: Pfizer Global Research & Development, 50 Pequot Ave. MS 6025-C2173, New London, CT 06320; 10: Hill Top Research, Bridgeton, MO; 11: Advanced Clinical Research, Salt Lake City, UT and Jordan Valley Family Health, West Jordan, UT; 12: Skila, Inc., Mahwah, NJ, USA 2: Ark-La-Tex Children’s Clinic, Bossier City, LA; 3: Central Kentucky Research Associates, Inc. and Pediatric Adolescent Associates, Lexington, KY; 4: Willis Knighton Portico Pediatrics, Shreveport, LA; 5: R/D Clinical Research, Inc. and Brazosport Pediatric Clinic, Lake Jackson, TX; 6: Hill Top Research, Inc. and Pediatric Associates of Dallas, Dallas, TX; 7: Radiant Research, Inc., Scottsdale, AZ; 8: Little Rock Children’s Clinic, Little Rock, AR; 9: Hill Top Research, Inc., Fresno, CA and Peachwood Medical Group, Clovis CA;

Publication date: 2003-09-01

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The Journal of Antimicrobial Chemotherapy is among the foremost international journals in antimicrobial research. Our readership includes representatives of academia, industry and health services, and includes those who are influential in formulary decisions.

Randomized, double-blind study of the clinical efficacy of 3 days of azithromycin compared with co-amoxiclav for the treatment of acute otitis media

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