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Single-dose azithromycin versus seven days of amoxycillin in the treatment of acute otitis media in Aboriginal children (AATAAC): a double blind, randomised controlled trial

Morris, Peter S., Gadil, Gaudencio, McCallum, Gabrielle B., Wilson, Cate A., Smith-Vaughan, Heidi C., Torzillo, Paul J. and Leach, Amanda J. (2010). Single-dose azithromycin versus seven days of amoxycillin in the treatment of acute otitis media in Aboriginal children (AATAAC): a double blind, randomised controlled trial. Medical Journal of Australia,192(1):24-29.

Document type: Journal Article
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IRMA ID 81704288xPUB32
Title Single-dose azithromycin versus seven days of amoxycillin in the treatment of acute otitis media in Aboriginal children (AATAAC): a double blind, randomised controlled trial
Author Morris, Peter S.
Gadil, Gaudencio
McCallum, Gabrielle B.
Wilson, Cate A.
Smith-Vaughan, Heidi C.
Torzillo, Paul J.
Leach, Amanda J.
Journal Name Medical Journal of Australia
Publication Date 2010
Volume Number 192
Issue Number 1
ISSN 0025-729X   (check CDU catalogue open catalogue search in new window)
Start Page 24
End Page 29
Total Pages 6
Place of Publication Australia
Publisher Australasian Medical Publishing Company Pty. Ltd.
Abstract Objective: To compare the clinical effectiveness of single-dose azithromycin treatment with 7 days of amoxycillin treatment among Aboriginal children with acute otitis media (AOM) in rural and remote communities in the Northern Territory.

Design, setting and participants: Aboriginal children aged 6 months to 6 years living in 16 rural and remote communities were screened for AOM. Those diagnosed with AOM were randomly allocated to receive either azithromycin (30 mg/kg as a single dose) or amoxycillin (50mg/kg/day in two divided doses for a minimum of 7 days). We used a double-dummy method to ensure blinding. Our study was conducted from 24 March 2003 to 20 July 2005.

Main outcome measures: Failure to cure AOM by the end of therapy; nasal carriage of Streptococcus pneumoniae and non-capsular Haemophilus influenzae (NCHi).

Results: We followed 306 of 320 children (96%) allocated to the treatment groups. Single-dose azithromycin did not reduce (or increase) the risk of clinical failure (50% failure rate [82/165]) compared with amoxycillin (54% failure rate [83/155]) (risk difference [RD], – 4% [95% CI, – 15% to 7%]; P = 0.504). Compared with amoxycillin, azithromycin significantly reduced the proportion of children with nasal carriage of S. pneumoniae (27% v 63%; RD, – 36% [95% CI, – 47% to – 26%]; P < 0.001) and NCHi (55% v 85%; RD, – 30% [95% CI, – 40% to – 21%]; P < 0.001). Nasal carriage of S. pneumoniae with intermediate or full resistance to penicillin was lower (but not significantly so) in the azithromycin group (10% v 16%), but this group had significantly increased carriage of azithromycin-resistant S. pneumoniae (10% v 3%; RD, 7% [95% CI, 0.1% to 12%]; P = 0.001). Carriage of β-lactamase-producing NCHi was about 5% in both groups.

Conclusion: Although azithromycin reduced nasal carriage of S. pneumoniae and NCHi, clinical failure was high in both treatment groups. The possibility of weekly azithromycin treatment in children with persistent AOM should be evaluated.

Trial registration: Australian Clinical Trials Registry ACTRN 12609000691246.
Description for Link Link to published version
URL https://www.mja.com.au/journal/2010/192/1/single-dose-azithromycin-versus-seven-days-amoxycillin-treatment-acute-otitis


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