The Runny Ear Study: REST

Phase 1

• Conditions: Acute Otitis Media with discharge; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2017-003635-10-GB
• Lead Sponsor: niversity of Bristol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-04
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 399

Inclusion Criteria

1. Children aged =12 months to <16 years;
2. Presenting with recent onset (=7 days) unilateral AOM with recent onset (=7 days) otorrhoea currently visible (or seen by parent/carer =24 hours);
3. Child attending with parent/carer who is legally able to give consent in person or parent able to give verbal consent via telephone call;
4. Parent/carer willing and able to administer ear drops;
5. Parent/carer willing, able and available to complete the daily SRQ and received regular telephone calls from the study team.

Are the trial subjects under 18? yes
Number of subjects for this age range: 399
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Symptoms/signs suggestive of bilateral AOM/AOMd;
2. Child has symptoms/signs suggestive of serious illness and/or complications e.g. mastoiditis and/or requires immediate hospitalisation;
3. Child requires immediate oral antibiotics (e.g. for another infection or AOMd considered severe);
4. As per NICE guidelines, child at high risk of serious complications:
• Significant immunosuppression;
• Heart, lung, renal, liver or neuromuscular disease (defined as requiring ongoing inpatient or outpatient care from specialist teams) co morbidities;
• Trisomy 21 (Down’s Syndrome), Cystic Fibrosis or craniofacial malformation such as cleft palate (these children are known to be at higher risk of AOM).
5. Grommet (ventilation tube) in situ in the otorrhoea ear;
6. Currently on oral (for a respiratory tract infection) or topical (in the affected ear) antibiotics;
7. Known allergy or sensitivity to ciprofloxacin;
8. Child has taken part in any research involving medicines within the last 90 days;
9. Child has already participated in this trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified