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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

Peter S Morris, Gaudencio Gadil, Gabrielle B McCallum, Cate A Wilson, Heidi C Smith-Vaughan, Paul Torzillo and Amanda J Leach
Med J Aust 2010; 192 (1): 24-29.

Summary

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.

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  • Peter S Morris1,2,3
  • Gaudencio Gadil1,2
  • Gabrielle B McCallum1,2
  • Cate A Wilson1,2
  • Heidi C Smith-Vaughan1,2
  • Paul Torzillo4
  • Amanda J Leach1,2

  • 1 Child Health Division, Menzies School of Health Research, Darwin, NT.
  • 2 Institute of Advanced Studies, Charles Darwin University, Darwin, NT.
  • 3 Northern Territory Clinical School, Flinders University, Darwin, NT.
  • 4 Royal Prince Alfred Hospital, Sydney, NSW.


Acknowledgements: 

The National Health and Medical Research Council provided funding for our study but had no role in data analysis or manuscript preparation. We thank the families and children who participated in our study, the NT Department of Health and Families, the community health boards, and staff at the 16 clinics involved. We also thank the following AATAAC collaborators for their contributions to the field and laboratory data collection and analysis and assistance with reviewing our manuscript: Stephen Halpin and Joseph McDonnell (statistical analysts); Katrina Hodson and Susie Hopkins (clinical data collectors); Mandy Kennedy, Elizabeth Stubbs and Kim Hare (laboratory scientists); Jemima Beissbarth (laboratory scientist and data manager); Marius Puruntatameri (Indigenous Elder and study advocate); Kathy Currie (audiologist and study advocate); and Keith Edwards (paediatrician and study advocate).

Competing interests:

None identified.

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