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

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.

Otitis media in children vaccinated during consecutive 7-valent or 10-valent pneumococcal conjugate vaccination schedules

“…The PHiD-CV10 group had a lower mean household number of children under the age of 5 years compared to the PCV7 group and significantly greater exposure to recent beta-lactam antibiotics. The antibiotics prescribed could be either protective [15-17], or indicative of a recent OM episode. The multivariate analysis of risk factors for suppurative OM confirmed that recent antibiotic prescribing was neither a significant risk nor protective factor for suppurative OM.…”

Geographic consistency in dominant, non-typeable Haemophilus influenzae genotypes colonising four distinct Australian paediatric groups: a cohort study

“…In the Northern Territory paediatric cohorts (Study 1 and Study 2), the mean NTHi carriage rates across all swabs were approximately 50 % (unpublished) for Study 1 and 85 % (269/316) at baseline for Study 2 [11] (Table 1). In the Kalgoorlie studies, NTHi carriage rates among the Aboriginal (Study 3) and non-Aboriginal (Study 4) children were 36.3 % (183/504) and 9.4 % (98/1045), respectively [14].…”

“…We attempted to screen all age-eligible children for AOM. Children with AOM whose parents consented were enrolled in a randomised-controlled trial of antibiotics for AOM [11]. Study 3 and Study 4 included Aboriginal and non-Aboriginal children, respectively, from the semi-arid town of Kalgoorlie in southern Western Australia enrolled in a prospective study of otitis media and nasopharyngeal carriage [12].…”

“…per 100 swabs)1Cluster RCT of a hygiene intervention in 20 Darwin (NT) child care centres.90 % were non-Aboriginal [10]2001456(50 %)0–4 yrs, attending 3 d/wkFortnightly for 6 m(2,012)2,179(2,201)84(4)2RCT of azithromycin vs amoxicillin for AOM in 16 remote NT communities. All were Aboriginal children [11]2003–2005320(316 with swab data)(85 %)0.5–6 yrs with AOMDays 0 and 6–11. Additionally, Day 12–21 if perforation.(469)551(569)73(13)3Kalgoorlie (WA) Otitis Media Research Project.…”

Macrolide resistance in pneumococci—is it relevant?

“…A clinical trial performed in a setting where resistance was relatively uncommon suggests that clinical outcomes of single dose azithromycin are similar to a 7-day course of amoxicillin, as well as reducing nasal pneumococcal carriage [24]. However, a higher proportion of the children on azithromycin that did carry pneumococci had resistance (10 % vs. 3 %, p  = 0.001), suggesting that resistance may attenuate this benefit over time.…”