JAC Advance Access published online on July 29, 2003
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkg358
© 2003 by The British Society for Antimicrobial Chemotherapy
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Original article
1 Pfizer Global Research & Development,
50 Pequot Ave. MS 6025-C2173, New London, CT 06320;
* Corresponding author. E-mail: michael_w_dunne{at}groton.pfizer.com.
Received 7 March 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
Randomized, double-blind study of the clinical
efficacy of 3 days of azithromycin compared with co-amoxiclav for
the treatment of
acute otitis media
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
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