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)

Among Aboriginal children (2 months of age and up to 17 years of age) with chronic suppurative otitis media, is oral cotrimoxazole (for 4 months) and/or povidone-iodine ear wash (until ear discharge resolves) in addition to standard treatment (cleaning and dry mopping with tissue spears plus topical ciprofloxacin until ear discharge resolves) superior to standard treatment alone for resolving ear discharge? A 2x2 factorial randomised controlled trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000234617

Acronym

I HEAR BETA (Indigenous Healthy EARs- BEtadine, Tissues and Antibiotics)

Enrollment

280

Registered

2014-03-05

Start date

2015-03-09

Completion date

2017-12-31

Last updated

2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 continue until the ear has been without discharge for 3 days (confirmed on two clinical examinations at least 3 days apart). Children will be randomised into one of four treatment arms. All treatments will commence at the same time (day one at randomisation). All arms will receive standard recommended topical treatment (dry mopping with tissue spears and ciprofloxacin drops 5 drops twice a day) PLUS either: ARM 1: Oral cotrimoxazole and topical Povidone-iodine ear washouts or, ARM 2: Oral cotrimoxazole and NO topical Povidone-iodine ear washouts or, ARM 3: Oral placebo and topical Povidone-iodine ear washouts or, ARM 4: Oral placebo and NO topical Povidone-iodine ear washouts. Children who respond to treatment and then develop a recurrence of ear discharge will receive their original allocated topical treatment regimen. Families will be shown how to perform the ear washes and given treatment packs. To measure adherence, we will ask families to return their used or unused treatment packs and ask families during follow-up phone calls and at the 16 week check-up about their treatment preferences and compliance issues.

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

2 Months to 17 Years

Healthy volunteers

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.

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.

Outcome results