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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.
Med J Aust 2010; 192(1):24-9MJ

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 beta-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.

Authors+Show Affiliations

Child Health Division, Menzies School of Health Research, Darwin, NT, Australia.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20047544

Citation

Morris, Peter S., et al. "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." The Medical Journal of Australia, vol. 192, no. 1, 2010, pp. 24-9.
Morris PS, Gadil G, McCallum GB, et al. 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. Med J Aust. 2010;192(1):24-9.
Morris, P. S., Gadil, G., McCallum, G. B., Wilson, C. A., Smith-Vaughan, H. C., Torzillo, P., & Leach, A. 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. The Medical Journal of Australia, 192(1), pp. 24-9.
Morris PS, et al. 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. Med J Aust. 2010 Jan 4;192(1):24-9. PubMed PMID: 20047544.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Morris,Peter S, AU - Gadil,Gaudencio, AU - McCallum,Gabrielle B, AU - Wilson,Cate A, AU - Smith-Vaughan,Heidi C, AU - Torzillo,Paul, AU - Leach,Amanda J, PY - 2009/05/12/received PY - 2009/08/17/accepted PY - 2010/1/6/entrez PY - 2010/1/6/pubmed PY - 2010/2/24/medline SP - 24 EP - 9 JF - The Medical journal of Australia JO - Med. J. Aust. VL - 192 IS - 1 N2 - 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 beta-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. SN - 0025-729X UR - https://www.unboundmedicine.com/medline/citation/20047544/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_ L2 - https://www.mja.com.au/public/issues/192_01_040110/mor10590_fm.html DB - PRIME DP - Unbound Medicine ER -