Clinical Trial Results:
Immediate oral, immediate topical or delayed oral antibiotics for acute otitis media with discharge (the Runny Ear STudy: REST)
Summary
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EudraCT number |
2017-003635-10 |
Trial protocol |
GB |
Global end of trial date |
25 Sep 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Apr 2021
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First version publication date |
25 Apr 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
2814
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
University of Bristol
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Sponsor organisation address |
Beacon House, Queens Road, Bristol, United Kingdom,
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Public contact |
Centre for Academic Primary Care, University of Bristol, +44 01179287350, rest-study@bristol.ac.uk
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Scientific contact |
Centre for Academic Primary Care, University of Bristol, +44 01179287350, rest-study@bristol.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
25 Aug 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Oct 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
25 Sep 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine whether either ciprofloxacin 0.3% drops, or delayed oral amoxicillin (clarithromycin if penicillin allergic or other suitable oral antibiotic as chosen by the GP), is non-inferior to current usual care (immediate oral antibiotics) for overall illness duration in children with AOMd presenting to primary care.
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Protection of trial subjects |
Details of adverse events were reported via parent completed questionnaire and collected by the study team.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 22
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Worldwide total number of subjects |
22
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
4
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Children (2-11 years) |
16
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Adolescents (12-17 years) |
2
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||
Pre-assignment
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Screening details |
Screening was automated by the TRANSFORM software when a child with ear discharge presented (with parent/guardian) to a recruiting practice. Participant eligibility was then confirmed by the recruiting clinician. | ||||||||||||
Period 1
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Period 1 title |
Overall trial period (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Immediate topical ear drops | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Immediate ciprofloxacin (0.3%) ear drop solution
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Ear drops
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Routes of administration |
Auricular use
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Dosage and administration details |
Immediate ciprofloxacin (0.3%) ear drop solution, four drops given three times a day for 7 days, with an advice sheet on how to administer the ear drops and standardised symptom management advice.
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Arm title
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Delayed oral amoxicillin | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Delayed oral amoxicillin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral liquid
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Routes of administration |
Oral use
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Dosage and administration details |
Delayed dose-by-age oral amoxicillin suspension given three times a day for 7 days, and an advice sheet containing structured delaying advice and standardised symptom management advice.
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Arm title
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Immediate oral amoxicillin | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
Active comparator | ||||||||||||
Investigational medicinal product name |
Immediate oral amoxicillin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral liquid
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Routes of administration |
Oral use
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Dosage and administration details |
Immediate dose-by-age oral amoxicillin given three times a day for 7 days, and standardised symptom management advice.
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Baseline characteristics reporting groups
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Reporting group title |
Immediate topical ear drops
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Delayed oral amoxicillin
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Immediate oral amoxicillin
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Immediate topical ear drops
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Reporting group description |
- | ||
Reporting group title |
Delayed oral amoxicillin
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Reporting group description |
- | ||
Reporting group title |
Immediate oral amoxicillin
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Reporting group description |
- |
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End point title |
Primary Outcome: Duration of symptoms [1] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
From baseline up to 14 days
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The trial was stopped early due to lack of recruitment, as such no formal between group statistical analyses were performed. |
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No statistical analyses for this end point |
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End point title |
Secondary Outcome: N with symptoms resolved by day 3 | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline to 3 days
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No statistical analyses for this end point |
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End point title |
Secondary Outcome: Time to symptoms rated as 'slight problem' or better | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline up to 14 days
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No statistical analyses for this end point |
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End point title |
Secondary Outcome: N with symptoms rated "slight problem" or better by day 3 | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline to day 3
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No statistical analyses for this end point |
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End point title |
Secondary Outcome: Duration of moderate or worse pain | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline to 14 days
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No statistical analyses for this end point |
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End point title |
Secondary Outcome: Duration of moderate or worse fever | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline up to 14 days
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No statistical analyses for this end point |
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End point title |
Secondary Outcome: Duration of moderate or worse ear discharge | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline up to 14 days
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No statistical analyses for this end point |
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End point title |
Secondary Outcome: Duration of moderate or worse unwell | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline up to 14 days
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No statistical analyses for this end point |
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End point title |
Secondary Outcome: Duration of moderate or worse sleep | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline up to 14 days.
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No statistical analyses for this end point |
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End point title |
Secondary Outcome: Duration of moderate or worse crying | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline up to 14 days
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No statistical analyses for this end point |
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End point title |
Secondary Outcome: Duration of moderate or worse eating/ drinking | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline up to 14 days.
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No statistical analyses for this end point |
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End point title |
Secondary Outcome: Duration of moderate or worse activities | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline up to 14 days
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No statistical analyses for this end point |
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End point title |
Secondary Outcome: Satisfaction with treatment at day 14 | ||||||||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 14
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
At Day 7 participants were asked to report on the previous 7 days. At Day 14 participants were asked to report on the previous 7 days.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
NA | ||||||||||||||||||||||||||||
Dictionary version |
NA
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Reporting groups
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Reporting group title |
Immediate topical ear drops
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Reporting group description |
- | ||||||||||||||||||||||||||||
Reporting group title |
Delayed oral amoxicillin
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Reporting group description |
- | ||||||||||||||||||||||||||||
Reporting group title |
Immediate oral amoxicillin
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Reporting group description |
- | ||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |