Abstract
BackgroundChronic 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.MethodsThis 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).DiscussionCurrent 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.Trial registrationThis trial (ACTRN12614000234617) was registered with ANZCTR on 05 April 2014.
Highlights
Chronic suppurative otitis media (CSOM) is a significant health issue affecting Aboriginal Australians
In 2013, remote Indigenous communities participating in ear and nasopharyngeal carriage surveillance found that around 50% of young children had otitis media with effusion (OME), 37% had acute otitis media (AOM without perforation), and 12% had chronic suppurative otitis media (CSOM). [1] CSOM is one of the most significant health problems affecting young Aboriginal children in Australia today [2, 3] having compounding effects on hearing, behaviour and learning
It was not that long ago that children with pus draining from their ears were a common sight in remote communities with more than 50% of young children in some remote communities having long term CSOM. [4, 5] the rates of CSOM have decreased, the Northern Territory (NT) hearing service reported that 53% of young Aboriginal children living in remote NT communities still have some form of hearing loss. [6, 7] Of all forms of ear disease, children diagnosed with CSOM had the highest levels of hearing loss
Summary
Study design This is a parallel group, 2 × 2 factorial design, randomised (allocation concealed), assessor blinded, controlled clinical trial. Randomisation Eligible children whose parent or guardian provided signed informed consent were randomised to one of the four treatment options according to a computer-generated sequence This was obtained by a phone call (interactive voice response system) to the NHMRC Clinical Trial Centre (CTC). Additional secondary outcomes at 4 months and 12 months from randomisation included the proportion of children with any carriage of pneumococci and any carriage of vaccine or non- vaccine serotype pneumococci and any carriage of NTHi. All children were followed up for any adverse events (AE) and serious adverse events (SAE) by reviewing the child’s clinic and hospital records and asking the parents about any side effects of the treatments between and at visits. All analysis will be twotailed and statistical significance will be set at p < 0.05, using Stata 15.1 (StataCorp, College Station, TX, USA)
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