The 2001 Recommendations for clinical care guidelines on the management of otitis media in Aboriginal and Torres Islander populations were revised in 2010. This 2020 update by the Centre of Research Excellence in Ear and Hearing Health of Aboriginal and Torres Strait Islander Children used for the first time the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

Chronic suppurative otitis media (CSOM) is a significant health issue affecting Aboriginal Australians. Long-term hearing loss can cause communication problems, educational disadvantage, and social isolation. Current standard treatment for CSOM in our region is twice daily dry mopping of the pus from the ear canal followed by instillation of ciprofloxacin antibiotic ear drops for up to 16 weeks, or until the discharge resolves for a period of 3 days. The treatment is long, laborious and fails to resolve ear discharge in 70% of cases in remote communities. Bacterial pathogens also persist. Povidone-iodine ear wash is the preferred method of clearing ear discharge in Western Australia. However, evidence of its effectiveness is lacking. In systematic reviews, topical antibiotics (ciprofloxacin) have been shown to be more effective than oral antibiotics or topical antiseptics. Currently, it is unclear whether there are any benefits of combining these treatments. This protocol describes a 2 × 2 factorial randomised controlled trial of two different interventions (povidone-iodine ear wash and oral cotrimoxazole), given as adjunctive therapy to standard treatment for CSOM. 280 children, between 2 months and 17 years of age, Indigenous or non-Indigenous, living in participating Northern Territory (NT) communities are randomised to standard treatment (dry mopping and ciprofloxacin drops) plus one of two topical treatments (dilute povidone-iodine ear wash or no wash) and one of two oral medication treatments (16 weeks of cotrimoxazole or placebo). Current treatment of CSOM in our region shows that eradication of bacterial pathogens from the middle ear space and dry ears is often not achieved. This trial will evaluate the efficacy of adjunctive treatments of antiseptic ear washes and oral antibiotics. Clinical, microbiological and hearing outcomes will be reported. This trial (ACTRN12614000234617) was registered with ANZCTR on 05 April 2014.

BackgroundPregnant women and infants <6 months old have a high baseline risk for pneumococcal disease compared to the general population, particularly among Indigenous populations living in poverty and low‐resource settings. Efficacy trials of pneumococcal vaccination in pregnancy examining adverse birth outcomes are lacking.AimsWe report adverse birth events as secondary outcomes from the ‘PneuMum’ randomised controlled trial of 23‐valent pneumococcal polysaccharide vaccination (23vPPV) in pregnancy (August 2006–January 2011).Materials and methodsAustralian Aboriginal women aged 17–39 years with singleton uncomplicated pregnancies were randomised (1:2 ratio) to receive 23vPPV or no 23vPPV in pregnancy at 30–36 weeks gestation. We compared risks of stillbirth, preterm birth, low birthweight (LBW), and small for gestational age (SGA) between vaccinated and unvaccinated pregnant women. Cox proportional hazard ratios (HRs) were calculated on an intention‐to‐treat basis.ResultsAmong 227 enrolled participants, 75 (33%) received 23vPPV in pregnancy. Risk differences in adverse birth outcomes between 23vPPV vaccinated and unvaccinated pregnant women were; preterm birth 9% vs 4% (HR 2.79; 95% CI 0.94–8.32) P = 0.07; LBW 9% vs 5% (HR 2.09; 95% CI 0.76–5.78) P = 0.15; and SGA 15% vs 17% (HR 1.02; 95% CI 0.50–2.06) P = 0.96. There were no stillbirths.ConclusionsWe found a numerically higher rate of preterm births among women who received 23vPPV in pregnancy compared to unvaccinated pregnant women. Although further investigation with larger participant numbers is needed to better evaluate this safety signal, the contribution of safety results from smaller studies using appropriate data analysis methodologies is critical, particularly as more clinical trials in pneumococcal vaccination in pregnancy are progressing.

Indigenous children in Australia’s Northern Territory are densely colonised with the pneumococcus within weeks of birth antecedent to a high prevalence of acute lower respiratory infection (ALRI). We assessed the impact of the 23-valent pneumococcal polysaccharide vaccine (23vPPV) in pregnancy against infant ALRI in this setting.

Background: We assessed maternal 23-valent pneumococcal polysaccharide (23vPPV) vaccine efficacy (VE) against middle ear disease and pneumococcal carriage amongst Australian Indigenous infants.Methods: In an open label, allocation concealed, outcome-assessor blinded, community stratified, randomised controlled trial, healthy pregnant Indigenous women aged 17-39 years in the Northern Territory of Australia received the 23vPPV (1:1:1) at: 30-36 weeks gestation, birth, or were unvaccinated (Clinical-Trials.gov NCT00714064). Co-primary outcomes were the point prevalences of infant middle ear disease and 23vPPV-type carriage at age 7 months.Results: The consent rate was 50% (313/632). Among 227 eligible participants randomised, retention rates were 86% (66/77) controls; 89% (67/75) pregnancy vaccinees; 88% (66/75) birth vaccinees. At infant age 7 months, ear disease prevalence was: 71% (47/66) controls, 63% (42/67) pregnancy vaccinees, 76% (50/66) birth vaccinees; and 23vPPV-type carriage was: 26% (17/66) controls, 18% (12/67) pregnancy vaccinees, 18% (12/66) birth vaccinees. For pregnancy vaccinees, VE was 12% (95% Cl -12% to 31%) against infant ear disease and 30% (95% CI -34% to 64%) against 23vPPV-type carriage. In a post-hoc analysis, VE against infant ear disease concurrent with carriage of 23vPPV or related types was 51% (95% CI -2% to 76%). There were no serious adverse effects following receipt of the 23vPPV in pregnancy or at birth.Conclusions: In a high risk population, our study was unable to demonstrate efficacy of 23vPPV in pregnancy against the co-primary outcomes of either all-cause infant ear disease or 23vPPV-type nasopharyngeal carriage at age 7 months. Efficacy against ear disease concurrent with carriage of vaccine-related serotypes (a more specific outcome) suggests 23vPPV in pregnancy may complement childhood pneumococcal vaccination programs. (C) 2015 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license.