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.
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.


METHODS
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.


METHODS
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 beta-lactamase-producing NCHi was about 5% in both groups.


CONCLUSIONS
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.


BACKGROUND
Australian Clinical Trials Registry ACTRN 12609000691246.
Morris
Peter S
PS
Child Health Division, Menzies School of Health Research, Darwin, NT, Australia.
Gadil
Gaudencio
G
McCallum
Gabrielle B
GB
Wilson
Cate A
CA
Smith-Vaughan
Heidi C
HC
Torzillo
Paul
P
Leach
Amanda J
AJ
D000658:Amoxicillin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001315:Australia; D017963:Azithromycin / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D016001:Confidence Intervals; D004311:Double-Blind Method; D005260:Female; D006193:Haemophilus influenzae / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D008297:Male; D009666:Nose / Q000187:drug effects / Q000382:microbiology; D016017:Odds Ratio; D010033:Otitis Media / Q000188:drug therapy* / Q000208:ethnology / Q000382:microbiology; D013296:Streptococcus pneumoniae / Q000302:isolation & purification; D018058:Tympanic Membrane Perforation
D000900:Anti-Bacterial Agents; D000658:Amoxicillin; D017963:Azithromycin