Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000950369p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
9/04/2026
Date registered
Help: Date registered
3/08/2026
Date last updated
Help: Date last updated
3/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
3/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Hydrogen peroxide for chronic suppurative otitis media
Scientific title
Hydrogen Peroxide for persistent chronic suppurative otitis media in First Nations children - time to test a cheap, frequently recommended, antiseptic treatment.
Additional trial identifiers [1] 316070 0
Nil
Universal Trial Number (UTN)
Trial acronym
HP4RE
Related trial records

Health condition
Health condition(s) studied:
Chronic suppurative otitis media 340537 0
Tympanostomy Tube Otorrhoea 340538 0
Condition category
Condition code
Ear 336738 336738 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
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.
Intervention code [1] 333090 0
Treatment: Other
Description of the comparator or control
Standard treatment alone (ear cleaning and topical 5 drops of 0.3% ciprofloxacin hydrochloride drops two to three times daily) administered by parents/carers for up to 8 weeks. Diary recording will be supported.
Control group
Active

Outcomes
Primary outcome [1] 344247 0
Proportion of children with clinical resolution of ear discharge between treatment groups
Timepoint [1] 344247 0
4 weeks post randomisation
Secondary outcome [1] 457231 0
Proportion of children with clinical resolution of ear discharge between treatment groups
Timepoint [1] 457231 0
2 weeks post randomisation
Secondary outcome [2] 457267 0
Proportion of children with clinical resolution of ear discharge between treatment groups
Timepoint [2] 457267 0
8 weeks post randomisation
Secondary outcome [3] 457268 0
Difference in average pure tone hearing level between treatment groups
Timepoint [3] 457268 0
post 8 week assessment, within 3 months, when audiological services are available
Secondary outcome [4] 457269 0
Proportion of children culture-positive for any otopathogen between treatment groups
Timepoint [4] 457269 0
4 weeks post randomisation
Secondary outcome [5] 457270 0
Proportion of children with discharge cessation for three consecutive days (clinical cure) in those with versus without any antibiotic-resistant bacteria
Timepoint [5] 457270 0
2, 4 or 8 weeks post randomisation
Secondary outcome [6] 457271 0
Bacteriome profile differences between the study sites
Timepoint [6] 457271 0
Baseline swabs, assessed at completion of trial
Secondary outcome [7] 457272 0
Bacteriome difference between treatment groups
Timepoint [7] 457272 0
4 weeks post randomisation swabs, assessed at completion of trial
Secondary outcome [8] 457273 0
Mycobiome differences between the study sites
Timepoint [8] 457273 0
Baseline swabs, assessed at completion of trial
Secondary outcome [9] 457274 0
Mycobiome comparison by treatment group
Timepoint [9] 457274 0
4 weeks post randomisation swabs, assessed at completion of trial

Eligibility
Key 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).
Minimum age
1 Years
Maximum age
17 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
- Previous randomisation
- Known allergy or skin reaction (inflammation or rash) to either ciprofloxacin or hydrogen peroxide
- Recent (within 6 months, excluding tympanostomy tube insertion) or scheduled ear surgery within 3 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is determined by computer-based central randomisation after eligibility is confirmed and child is enrolled into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software and stratified by urban vs remote (residence) and age (1-7 years or >7 years).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In a recent CSOM trial (ACTRN12614000234617), failure to resolve CSOM was reported in 50% overall of remote-living First Nations children (GNT1060764). Assuming a 20% (clinically significant) absolute increase in clinical resolution [discharge cessation] (i.e., 30% to 50%), we will enrol 274 children across the two sites allowing for up to 10% attrition. The power to achieve the sample size will be 90% at 5% significance level. Our previous CSOM clinical trial had achieved 95% follow up of First Nations children living in remote Aboriginal communities in the NT. As previously recommended by the First Nations Child Health Division Advisory Group at Menzies (when reviewing a trial currently in progress), non-Indigenous children will be eligible to participate in the trial so long as our ability to answer the question for First Nations children is not compromised.
A detailed statistical analysis plan (SAP) will be prepared prior to analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2026
Actual
Date of last participant enrolment
Anticipated
30/09/2029
Actual
Date of last data collection
Anticipated
25/11/2029
Actual
Sample size
Target
274
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT
Recruitment hospital [1] 29093 0
John Hunter Children's Hospital - New Lambton
Recruitment hospital [2] 29094 0
Royal Darwin Hospital - Tiwi
Recruitment postcode(s) [1] 45386 0
2305 - New Lambton
Recruitment postcode(s) [2] 45387 0
0810 - Tiwi
Recruitment postcode(s) [3] 45388 0
2292 - Broadmeadow

Funding & Sponsors
Funding source category [1] 320668 0
Government body
Name [1] 320668 0
NHMRC
Country [1] 320668 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Menzies School of Health Research
Address
Country
Australia
Secondary sponsor category [1] 323300 0
None
Name [1] 323300 0
Address [1] 323300 0
Country [1] 323300 0
Other collaborator category [1] 283837 0
University
Name [1] 283837 0
University of Newcastle
Address [1] 283837 0
Country [1] 283837 0
Australia
Other collaborator category [2] 283838 0
Hospital
Name [2] 283838 0
Royal Darwin Hospital
Address [2] 283838 0
Country [2] 283838 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 319210 0
Human Research Ethics Committee of the Northern Territory Health Department and Menzies School of Health Research
Ethics committee address [1] 319210 0
Ethics committee country [1] 319210 0
Australia
Date submitted for ethics approval [1] 319210 0
07/10/2025
Approval date [1] 319210 0
Ethics approval number [1] 319210 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 146614 0
Dr Jemima Beissbarth
Address 146614 0
John Mathews Building (Bldg 58), Royal Darwin Hospital Campus, Rocklands Drv, Casuarina, NT 0810
Country 146614 0
Australia
Phone 146614 0
+61 08 89468506
Fax 146614 0
Email 146614 0
[email protected]
Contact person for public queries
Name 146615 0
Jemima Beissbarth
Address 146615 0
John Mathews Building (Bldg 58), Royal Darwin Hospital Campus, Rocklands Drv, Casuarina, NT 0810
Country 146615 0
Australia
Phone 146615 0
+61 08 89468506
Fax 146615 0
Email 146615 0
[email protected]
Contact person for scientific queries
Name 146616 0
Jemima Beissbarth
Address 146616 0
John Mathews Building (Bldg 58), Royal Darwin Hospital Campus, Rocklands Drv, Casuarina, NT 0810
Country 146616 0
Australia
Phone 146616 0
+61 08 89468506
Fax 146616 0
Email 146616 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies testing whether findings can be repeated or confirmed
• Studies for improvement of ear health outcomes

When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Data sharing request system: Data can be requested via the Health Data Australia portal (https://researchdata.edu.au/health/) or by contacting the lead investigator at: [email protected] Any data use applications will be subject to HREC and local governance review.

Are there extra considerations when requesting access to individual participant data?
Yes: First Nations governance approvals and collaborative research agreement at parties own cost



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.