JAC Advance Access originally published online on July 29, 2003
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Journal of Antimicrobial Chemotherapy (2003) 52, 469-472
© 2003 The British Society for Antimicrobial Chemotherapy
Randomized, double-blind study of the clinical efficacy of 3 days of azithromycin compared with co-amoxiclav for the treatment of acute otitis media
1 Pfizer Global Research & Development, 50 Pequot Ave. MS 6025-C2173, New London, CT 06320; 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; 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
Received 7 March 2003; returned 27 April 2003; revised 30 May 2003; accepted 4 June 2003
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 x 3 days or co-amoxiclav 45 mg/kg/day x 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: tympanic membrane disease, children, AOM
* Corresponding author. Tel: +1-860-732-3739; Fax: +1-860-732-7805; E-mail: michael_w_dunne{at}groton.pfizer.com
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