Hydrogen peroxide for chronic suppurative otitis media

Authors
Category Primary study
Registry of TrialsAustralian New Zealand Clinical Trials Registry
Year 2026
INTERVENTION: 1‐3mls (5 drops) of 3% hydrogen peroxide (diluted in water) twice daily, in addition to standard treatment (ear cleaning and topical 5 drops of 0.3% ciprofloxacin hydrochloride drops two‐three times daily), administered by parents/carers for up to 8 weeks (or until the ear is dry for three consecutive days). Diary recording methods will be supported. CONDITION: Chronic suppurative otitis media;Tympanostomy Tube Otorrhoea; ; Chronic suppurative otitis media ; Tympanostomy Tube Otorrhoea Ear ‐ Other ear disorders PRIMARY OUTCOME: Proportion of children with clinical resolution of ear discharge between treatment groups[Ear assessment by otoscopic examination confirming dry ears (absence of ear discharge/pus) 4 weeks post randomisation] INCLUSION CRITERIA: Unilateral or bilateral persistent or recurrent CSOM, including discharge through a tympanostomy tube. CSOM will be defined as discharge for more than 2 weeks through a hole in the eardrum of greater than 2% of the pars tensa (main part of the ear drum) or through a tympanostomy tube. Persistent CSOM will be defined as ongoing discharge despite at least 4 weeks of recommended treatment. Recurrent CSOM will be defined as recurrence of discharge (3 or more episodes within 6 months). SECONDARY OUTCOME: Bacteriome difference between treatment groups[Long read 16S rRNA gene amplicon sequencing 4 weeks post randomisation swabs, assessed at completion of trial ] Bacteriome profile differences between the study sites[Long read 16S rRNA gene amplicon sequencing Baseline swabs, assessed at completion of trial] Difference in average pure tone hearing level between treatment groups[Standard audiometric assessment appropriate to child age as obtained via referral to local audiology service post 8 week assessment, within 3 months, when audiological services are available] Mycobiome comparison by treatment group [Amplicon sequencing of the internal transcribed spacer regions to identify fungal and yeast species and communities present in ear discharge. This will be assessed as a community profile (including fungi and yeasts) level outcome. 4 weeks post randomisation swabs, assessed at completion of trial ] Mycobiome differences between the study sites [Amplicon sequencing of the internal transcribed spacer regions to identify fungal and yeast species and communities present in ear discharge. This will be assessed as a community profile (including fungi and yeasts) level outcome. Baseline swabs, assessed at completion of trial] Proportion of children culture‐positive for any otopathogen between treatment groups[Microbiologic culture of ear discharge swabs 4 weeks post randomisation] Proportion of children with clinical resolution of ear discharge between treatment groups[Ear assessment by otoscopic confirming dry ears (absence of ear discharge/pus) 2 weeks post randomisation] Proportion of children with clinical resolution of ear discharge between treatment groups[Ear assessment by otoscopic examination confirming dry ears (absence of ear discharge/pus) 8 weeks post randomisation] Proportion of children with discharge cessation for three consecutive days (clinical cure) in those with versus without any antibiotic‐resistant bacteria [Antibiotic‐resistance analysed microbiologic culture 2, 4 or 8 weeks post randomisation]
Epistemonikos ID: ed953a2c217ce74d8cb4af660b899a94522767ef
First added on: Sep 12, 2026