A study to see how best to treat ear discharge in children

ISRCTN	ISRCTN22413988
DOI	https://doi.org/10.1186/ISRCTN22413988
Integrated Research Application System (IRAS)	1012973
Central Portfolio Management System (CPMS)	75834
Sponsor's protocol code number	B02775
Sponsor	Manchester University NHS Foundation Trust
Funder	National Institute for Health and Care Research

Submission date: 11/08/2026
Registration date: 14/08/2026
Last edited: 22/10/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This study looks at the best way to treat ear infections in children when fluid leaks from the ear. This condition is called acute otitis media with discharge. It happens when an infected eardrum bursts and liquid drains out. The study aims to compare two treatments: oral antibiotics and antibiotic ear drops. Researchers want to find out if it is possible to run a larger study in the future and whether parents can use a remote online consent process.

Who can participate?
Children aged 6 months to under 7 years can take part if they have a new episode of ear discharge lasting less than 6 weeks. They must not have had antibiotics recently. Children cannot take part if they have serious illness, complications of ear infections, certain medical conditions of the ear, or allergies to the study medicines.

What does the study involve?
Children will be chosen at random to receive either oral antibiotics or antibiotic ear drops for 7 days. Parents will be contacted by the study team through phone calls and text messages to check how their child is doing and whether the ear discharge has stopped. The design aims to fit around busy family life.

What are the possible benefits and risks of participating?
Children may benefit from treatment that helps clear their ear infection. The study may also help improve care for future families. Risks include possible side effects from antibiotics, such as stomach upset from oral medicines. Ear drops carry very little risk because they are absorbed into the body at low levels. If any problems occur, families can contact the study team.

Where is the study run from?
The study is run from Manchester University NHS Foundation Trust, with clinical work based at Royal Manchester Children’s Hospital.

When is the study starting and how long is it expected to run for?
November 2026 to September 2027

Who is funding the study?
National Institute for Health and Care Research (UK).

Who is the main contact?
Mr Elliot Heward at the Paediatric ENT research office, Royal Manchester Children’s Hospital, e.heward@nhs.net

Contact information

Mr Elliot Heward
Scientific, Public

Paediatric ENT research office
Royal Manchester Children's Hospital
Manchester
M13 9WL
United Kingdom

ORCID ID	0000-0002-9692-646X
Phone	+44 1612765606
Email	e.heward@nhs.net

Dr Lynne Webster
Scientific, Public

Research Office Manchester University NHS Foundation Trust 1st Floor NOWGEN Centre 29 Grafton Street
Manchester
M13 9WU
United Kingdom

Phone	+44 161 701 5057
Email	Research.Sponsor@mft.nhs.uk

Dr Iain Bruce
Principal investigator

Oxford Road
Manchester
M13 9WL
United Kingdom

Phone	+44 161 276 5606
Email	iain.bruce@mft.nhs.uk

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Treatment, Efficacy, Feasibility
Scientific title	Management of acute Ear Discharge in Children (MEDIC): a feasibility study
Study acronym	MEDIC
Study objectives	1. To see if running a study comparing antibiotics taken by mouth against drop antibiotics into the ear for treating acute otitis media with discharge is possible. The study is using a remote consent and follow up methods which need to be tested before we run a full large scale study. This is called a feasibility study 2. To see if there are any problems using the medications in children and to help find out the number of children that are required for the full large scale study (called sample size calculation)
Ethics approval(s)	Approved 19/10/2026, Hampshire B Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)2071048260; hampshireb.rec@hra.nhs.uk), ref: 26/SC/0283
Health condition(s) or problem(s) studied	Acute otitis media with discharge
Intervention	Control arm: Oral Amoxicillin or Clarithromycin. Amoxicillin dosed by age for 7 days. Clarithromycin doses by weight for 7 days. Intervention arm: Ciprofloxacin topical drops. One ampule (0.25ml) of 2mg/ml drops twice daily for 7 days. Follow up for all participants: 14 days Randomisation: individual online tool
Intervention type	Drug
Phase	Phase III
Drug / device / biological / vaccine name(s)	Amoxicillin, clarithromycin, ciprofloxacin
Primary outcome measure(s)	Feasibility outcomes: 1. Number of patients referred to the study during recruitment measured using study database at the end of the study 2. Time from referral to remote consultation with research doctor measured using study database at the end of the study 3. Proportion of patients choosing medication collection measured using study database at the end of the study 4. Time from prescription to medication delivery or collection measured using study database at the end of the study 5. Proportion of patients randomised of those referred to the study measured using study database at the end of the study 6. Participant-reported adherence to treatment measured using study database at the end of the study 7. Proportion of patients with complete follow-up data measured using study database at the end of the study 8. Time to cessation of otorrhoea measured using study database at the end of the study
Key secondary outcome measure(s)	1. Time to cessation of ear discharge (otorrhoea) measured using daily text message question response 2. Resolution of ear discharge measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement 3. Pain severity measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement 4. Pain duration measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement 5. Fever episodes measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement 6. Sleep disturbance measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement 7. Appetite disturbance measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement 8. Complications of infection measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement 9. Healthcare interactions measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement 10. Adverse drug reactions measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement
Completion date	30/09/2027

Eligibility

Participant type(s)
Age group	Child
Lower age limit	6 Months
Upper age limit	7 Years
Sex	All
Target sample size at registration	60
Key inclusion criteria	Current key inclusion criteria: 1. Children and young people aged ≥6 months and <7 years 2. Unilateral or bilateral otorrhoea 3. New episode of otorrhoea (>6 weeks from previous episode) 4. Otorrhoea duration <6 weeks 5. No prior antibiotic treatment for this episode 6. No antibiotics for other reasons within 6 weeks prior 7. Parent/guardian who can understand written English, Urdu, Arabic, Punjabi or Polish Previous key inclusion criteria: 1. Children and young people aged ≥6 months and <7 years 2. Unilateral or bilateral otorrhoea 3. New episode of otorrhoea (>6 weeks from previous episode) 4. Otorrhoea duration <6 weeks 5. No prior antibiotic treatment for this episode 6. No antibiotics for other reasons within 6 weeks prior 7. Parent/guardian who is able to understand written English, Urdu, Arabic, Punjabi or Polish
Key exclusion criteria	Current key exclusion criteria: 1. Signs of sepsis (requiring hospitalisation) 2. Complications of ear infections (e.g. mastoiditis, facial nerve palsy, brain abscess, meningitis) 3. Significant immunosuppression 4. Known grommet in the affected ear 5. Known cholesteatoma in the affected ear 6. Hypersensitivity to ciprofloxacin or any member of the quinolone class of antimicrobial agents 7. Hypersensitivity to amoxicillin or to any of the penicillins, or history of a severe immediate hypersensitivity reaction to another betalactam agent (e.g. a cephalosporin, carbapenem or monobactam) and any contraindication to clarithromycin as per section 4.3 of the SmPC (not just allergy) 8. Currently participating in an ear related research study 9. Currently involved or have been involved with a trial which involves antibiotic treatment within the prior 6 weeks Previous key exclusion criteria: 1. Signs of sepsis (requiring hospitalisation) 2. Complications of ear infections (for example mastoiditis, facial nerve palsy, brain abscess, meningitis) 3. Significant immunosuppression 4. Known grommet in the affected ear 5. Known cholesteatoma in the affected ear 6. Allergy to ciprofloxacin 7. Allergy to both amoxicillin and clarithromycin 8. Currently participating in an ear related research study
Date of first enrolment	16/11/2026
Date of final enrolment	15/09/2027

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Manchester University NHS Foundation Trust

Cobbett House
Oxford Road
Manchester
M13 9WL
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

22/10/2026: Ethics approval added.
21/10/2026: The following changes were made:
1. Key inclusion and exclusion criteria were updated.
2. The date of first enrolment was changed from 30/09/2026 to 16/11/2026.
3. ISRCTN received notification of combined HRA/MHRA approval for this trial on 21/10/2026.
11/08/2026: Trial's existence confirmed by NHS HRA.