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)
Phase 4
Completed
- Conditions
- chronic suppurative otitis media (CSOM)Ear - Other ear disorders
- Registration Number
- ACTRN12614000234617
- Lead Sponsor
- Menzies School of Health Research
- Brief Summary
To be published
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 280
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>The primary analysis will report the absolute risk difference and 95% confidence interval for: <br>(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;<br>(ii) The difference in failure rates between children allocated to receive twice daily oral cotrimoxazole and children allocated to receive placebo.<br>[16 weeks (at the end of the intervention period)]
- Secondary Outcome Measures
Name Time Method Rates of clinical failure 12 months after randomisation will be analysed using an intention to treat analysis. 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.<br>[12 months (at the end of the study)]