The Runny Ear STudy (REST)

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 22

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

Exclusion Criteria

Current exclusion criteria as of 04/12/2018:
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 guidelines13, child at high risk of serious complications:
4.1. Significant immunosuppression
4.2. Heart, lung, renal, liver or neuromuscular disease (defined as requiring ongoing inpatient or outpatient care from specialist teams) co morbidities
4.3. 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. Allergy to ciprofloxacin
8. Allergy to penicillin/anaphylaxis to another beta lactam agent and allergy to clarithromycin
9. Child has already participated in this trial

Previous exclusion criteria 7 to 9:
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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Time to resolution of all of the following:<br> 1. Pain<br> 2. Fever<br> 3. Being unwell<br> 4. Sleep disturbance<br> 5. Otorrhoea<br> 6. Episodes of distress/crying being rated ‘no’ or ‘very slight’ problem (without need for analgesia)<br> Recorded by parents/carers using a validated Symptom and Recovery Questionnaire (SRQ) with Research Nurse telephone support at baseline to 14 days after randomisation<br>

Secondary Outcome Measures

Name	Time	Method

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