Aims:
- To determine the efficacy of topical and oral treatments for resolution of discharging ears among Aboriginal children with chronic suppurative otitis media (CSOM).
Objectives:
- To compare the efficacy of the following strategies reduce the proportion of children with discharging perforations after 16 weeks of treatment:
- twice daily antiseptic ear wash (>= 20mls povidine-iodine 0.5% solution syringed into the ear canal) prior to standard topical antibiotic treatment (compared to standard topical antibiotic treatment alone)
- twice daily oral antibiotic treatment (cotrimoxazole 4mg/kg per dose of trimethoprim component) given in addition to standard topical antibiotic treatment (compared to placebo).
Summary:
Otitis media is an important health problem affecting the hearing of up to 80% of remote Northern Territory (NT) Aboriginal children. Many have Chronic Suppurative Otitis Media (CSOM). Treatment guidelines recommend twice daily ear cleaning and ciprofloxacin drops with weekly clinic review and referral. In clinical trials, efficacy for this strategy is around 30%. Thus, hearing loss persists with long term implications for educational, social and behavioural problems.
West Australia's practice is to use dilute Betadine® ear washes. A Dutch study suggests that oral trimethoprim-sulfamethoxazole (cotrimoxazole) prolongs ear dryness in CSOM. Our microbiological work shows ongoing non-typable Haemophilus influenzae (NTHi) infection of the middle ear suggesting a role of nasopharyngeal (NP) colonisation and need for systemic antibiotics.
In this study Aboriginal children >6 months and <17 years of age will be screened for CSOM, aiming for 280 randomisations. Each consenting child will also receive usual care. Allocation will be stratified by community and age group. Ear and NP swabs will be taken. The study will use molecular typing to distinguish new NTHi infection from persistence (treatment failure). The primary outcome will be failure after a four month intervention period. Secondary outcomes will include hearing, adherence, microbiology, complications and side effects.
Implications for policy and practice:
This study is an important development for the assessment of interventions in Aboriginal health. It combines the recent experience of intensive studies involving small numbers of children with a practical approach to more effective medical treatments for an important and common health problem.
The results of the trial will become the best available evidence to guide the medical management of CSOM in high-risk children. It will be an important contribution to the medical literature and the results will have implications for all disadvantaged populations where adverse outcomes are common. This project will also provide improved training and education materials for a large number of NT health staff. Ongoing education and support is essential in the transition toward more effective prevention and management of chronic suppurative otitis media in Aboriginal children.
Chief investigator:
Project manager:
Contact information:
Project dates:
The study will commence in 2014 and conclude in 2017.
Funders:
- National Health and Medical Research Council (NHMRC)
Collaborators:
- Northern Territory Department of Health.
