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Table 1 Inclusion and exclusion criteria

From: A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare immediate orally administered, immediate topically administered or delayed orally administered antibiotics for acute otitis media with discharge in children: The Runny Ear Study (REST): study protocol

Patient selection criteria
Inclusion criteria (child must meet all 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/legal guardian ≤ 24 h)
3. Child attending with parent/legal guardian who is legally able to give consent in person
4. Parent/legal guardian willing and able to administer eardrops
5. Parent/legal guardian willing, able and available to complete the daily SRQ and received regular telephone calls from the study team
Exclusion criteria (excluded if child meets any criterion at the time of entry):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 orally administered antibiotics (e.g. for another infection or AOMd considered severe)
4. As per NICE guidelines [12], a 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 ear with otorrhoea
6. Currently taking orally (for a respiratory tract infection) or topically administered (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 taken part in any research involving medicines within the last 90 days
10. Child has already participated in this trial
  1. AOM acute otitis media, SRQ Standard Recovery Questionnaire