IHEARBETA Primary outcomes
Menzies School of Health ResearchDataset description
Demographics - Location (by Northern Territory region) - Ethnicity (all Australian First Nations) Baseline / randomisation characteristics (Table 1 in publication) - Birth characteristics (birth weight, gestational age, maternal smoking) - Randomisation characteristics (weight, age, breastfeeding status, household smoking, environmental smoke, family history 'runny ears') Randomisation allocation (treatment group) and treatment given Otitis media diagnosis at baseline, 16 weeks (primary outcome) and 12 months. Additional antibiotic management data (clinical failure) in the 16 week intervention period. Primary outcome hearing data. Basic microbiologic data from ear discharge.Identifiers
Source Study
Trial name (public)
Comparing cotrimoxazole and/or povidone-iodine ear wash with standard dry mopping and ciprofloxacin ear drops in Indigenous children with chronic suppurative otitis media (CSOM)Trial acronym
I HEAR BETA (Indigenous Healthy EARs- BEtadine, Tissues and Antibiotics)
Trial ID
ACTRN12614000234617
Purpose
Treatment
Phase
Phase 4
Funding
Government body,National Health and Medical Research Council (NHMRC)
Scientific enquiries
Prof Amanda Leach
Brief Summary
This is a 2x2 factorial design randomised controlled trial of 4 months therapy with oral cotrimoxazole versus placebo and topical povidone iodine versus no wash, in addition to standard treatment to resolve chronic suppurative otitis media (runny ears) in children 2 months to less than 17 years of age. Standard treatment is twice daily dry mopping and topical ciprofloxacin drops.
Key Inclusion Criteria
Indigenous children 2 months to 17 years of age and residing in participating communities, with a diagnosis of unilateral or bilateral chronic suppurative otitis media (CSOM) are eligible to participate in this study.
Key Exclusion Criteria
Children who are ineligible include those who; i) have been previously randomised; ii) have ciprofloxacin, cotrimoxazole or iodine allergy; iii) had mastoid surgery in the preceding 12 months; iv) have ear surgery scheduled in the next 4 months; v) have congenital ear or hearing problems; vi) are known to have immunodeficiency; or vii) are pregnant.
Can healthy volunteers participate?
No
Population
Sample Size 280
Min. age 2 Months
Max. age 17 Years
Sex Both males and females
Condition category chronic suppurative otitis media (CSOM)
Condition code Ear
Intervention
Intervention code Treatment: Drugs
Oral Intervention: Placebo or Sulfamethoxazole-trimethoprim (cotrimoxazole, 4mg/kg per dose of trimethoprim component) given orally twice daily for 16 weeks. Topical Intervention: Povidone-iodine 0.5% (Betadine 'registered trademark') given twice daily as an ear wash (1:20 mixed with clean water), >=20mls per discharging ear. This treatment will be given prior to the standard recommended treatment of dry mopping with tissue spears and ciprofloxacin drops. Topical treatment regimens should contin .... Read more
Comparison
Control group Placebo
There is one control arm (standard treatment only- no oral or additional topical intervention) and 3 comparator arms. Oral comparator/control: A placebo medication that is identical in appearance, smell and taste as cotrimoxazole. Topical comparator: no povidone-iodine wash. Standard topical treatment (Northern Territory) for all children: Dry mopping with tissue spears and ciprofloxacin drops 5 drops twice a day. Treatment regimens should continue until the ear has been without discharge for 3 .... Read more
Outcomes
Outcome: Failure will be defined as presence of ear discharge in either ear, assessed by a trained research nurse using video-otoscopy before cleaning the ear canal. The primary analysis will report the absolute risk difference and 95% confidence interval for: (i) The difference in failure rates between children allocated to receive the povidone-iodine ear wash plus standard treatment, and children allocated to receive standard treatment alone; (ii) The difference in failure r .... Read more