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Study protocol
A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare Immediate Oral, Immediate Topical or Delayed Oral Antibiotics for Acute Otitis Media with Discharge in children: The Runny Ear Study (REST): Study protocol.
Jodi Taylor
University of Bristol School of Social and Community Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0001-7171-8923
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with oral antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops or “delayed” oral antibiotics, could be at least as effective and safe as immediate oral antibiotics for children with AOMd.
Methods: REST is a pragmatic, three-arm, individually randomised, non-inferiority trial being conducted in 50 GP practices across the UK. The study aims to recruit 399 children aged (≥12m and <16yrs) presenting to their GP with AOMd. Children will be randomised to one of three arms: immediate ciprofloxacin 0.3% eardrops; delayed oral amoxicillin (clarithromycin if penicillin allergic); or immediate oral amoxicillin (clarithromycin).
Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform. Integrated within the primary care electronic medical records it provides automatic eligibility checking, part-filling of e-CRFs, study workflow management and routine NHS follow up data collection. The primary outcome is time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ). Secondary outcomes, including cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes, will be collected at day 14 and at 3 months.
Discussion: It is unclear whether prescribing oral antibiotics to children with AoMd results in a reduction in symptoms or a shorter duration of illness. The REST trial will allow us to compare the non-inferiority of: immediate topical ciprofloxacin ear drops, or delayed oral amoxicillin (clarithromycin) against immediate oral amoxicillin (clarithromycin). We aim to recruit 399 patients from 175 practices in the UK. Using the Transform software to randomise participants to the trial will enable recruitment for a relatively uncommon condition.
Trial registration:
Name of Registry: ISCRTN
Registration Number: ISRCTN12873692 This contains all items required to comply with the World Health Organization Trial Registration Data Set
Date of Registration: 24th April 2018
http://www.isrctn.com/ISRCTN12873692
Name of Registry: EudraCT
Registration Number: 2017-003635-10
Date of Registration: 6TH September 2017
Keywords
Acute otitis media; primary care; antibiotics; paediatrics; Randomised Controlled Trial
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CURRENT STATUS: Under Review
Version 2
Posted 19 May, 2020
No community comments so far
Editor assigned
On 08 May, 2020
Submission checks complete
On 11 Apr, 2020
No comments provided
Review #1 received
Received 27 Apr, 2020
Editorial decision: Minor revision
On 27 Apr, 2020
Reviewers invited
Invitations sent on 21 Apr, 2020
Reviewer #1 agreed
On 21 Apr, 2020
Editor assigned
On 18 Apr, 2020
Submission checks complete
On 12 Apr, 2020
First submitted
On 27 Mar, 2020
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare Immediate Oral, Immediate Topical or Delayed Oral Antibiotics for Acute Otitis Media with Discharge in children: The Runny Ear Study (REST): Study protocol.
Jodi Taylor
University of Bristol School of Social and Community Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0001-7171-8923
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 2
Posted 19 May, 2020
No community comments so far
Editor assigned
On 08 May, 2020
Submission checks complete
On 11 Apr, 2020
No comments provided
Review #1 received
Received 27 Apr, 2020
Editorial decision: Minor revision
On 27 Apr, 2020
Reviewers invited
Invitations sent on 21 Apr, 2020
Reviewer #1 agreed
On 21 Apr, 2020
Editor assigned
On 18 Apr, 2020
Submission checks complete
On 12 Apr, 2020
First submitted
On 27 Mar, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with oral antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops or “delayed” oral antibiotics, could be at least as effective and safe as immediate oral antibiotics for children with AOMd.
Methods: REST is a pragmatic, three-arm, individually randomised, non-inferiority trial being conducted in 50 GP practices across the UK. The study aims to recruit 399 children aged (≥12m and <16yrs) presenting to their GP with AOMd. Children will be randomised to one of three arms: immediate ciprofloxacin 0.3% eardrops; delayed oral amoxicillin (clarithromycin if penicillin allergic); or immediate oral amoxicillin (clarithromycin).
Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform. Integrated within the primary care electronic medical records it provides automatic eligibility checking, part-filling of e-CRFs, study workflow management and routine NHS follow up data collection. The primary outcome is time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ). Secondary outcomes, including cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes, will be collected at day 14 and at 3 months.
Discussion: It is unclear whether prescribing oral antibiotics to children with AoMd results in a reduction in symptoms or a shorter duration of illness. The REST trial will allow us to compare the non-inferiority of: immediate topical ciprofloxacin ear drops, or delayed oral amoxicillin (clarithromycin) against immediate oral amoxicillin (clarithromycin). We aim to recruit 399 patients from 175 practices in the UK. Using the Transform software to randomise participants to the trial will enable recruitment for a relatively uncommon condition.
Trial registration:
Name of Registry: ISCRTN
Registration Number: ISRCTN12873692 This contains all items required to comply with the World Health Organization Trial Registration Data Set
Date of Registration: 24th April 2018
http://www.isrctn.com/ISRCTN12873692
Name of Registry: EudraCT
Registration Number: 2017-003635-10
Date of Registration: 6TH September 2017
Figure 1
Figure 2