Acute otitis media with discharge (AOMd) Ear, Nose and Throat Otitis media, unspecified
Conditions
Interventions
Children will be randomised, stratified by age (<2 years and =2 years, since children <2 years’ experience longer illness duration). Two randomisation lists will be generated as per the stratification
Sponsors
The University Of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to resolution of all of the following: 1. Pain 2. Fever 3. Being unwell 4. Sleep disturbance 5. Otorrhoea 6. Episodes of distress/crying being rated ‘no’ or ‘very slight’ problem (without need for analgesia) Recorded by parents/carers using a validated Symptom and Recovery Questionnaire (SRQ) with Research Nurse telephone support at baseline to 14 days after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will include (as recorded in the first 14 days of participant entry to the trial on the symptom recovery questionnaire): 1. Time until symptoms (pain, fever, being unwell, sleep disturbance, otorrhoea, episodes of distress/crying, appetite and interference with normal activities) are no longer rated ‘moderately bad or worse’ (score of =3 on validated scale) measured using the symptom recover questionnaire 2. Adverse events diarrhoea, rash, vomiting and severe complications measured on the symptom recovery questionnaire at day 7 and 14 3. Parent carer satisfaction with treatment is measured on the symptom recovery questionnaire at day 14 4. Treatment adherence and analgesic use to symptom resolution is measured using the symptom recovery questionnaire up to day 14 5. Details of NHS resource use is measured using the symptom recovery questionnaire at day 7 and 14 6. Burden of resistance is measured using stool sample at day 7 and 3 months | — |
Countries
United Kingdom
Contacts
Public ContactKathryn Curtis
Outcome results
None listed