Contact information
Type
Scientific
Primary contact
Dr Paul Little
ORCID ID
Contact details
Primary Medical Care
Aldermoor Health Centre
Aldemoor Close
Southampton
SO15 6ST
United Kingdom
+44 (0)2380 241050
pmc1@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SPGS784
Study information
Scientific title
Acronym
Study hypothesis
To determine the pragmatic outcomes of commonly used management strategies for acute red ear in primary care
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Ear, nose and throat diseases: Ear, nose and throat diseases
Intervention
Course of amoxycillin (125 mg tds 1 week) or course of amoxycillin on request after 72 hrs
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Symptom resolution, analgesia use, antibiotic use, fever resolution, complication rate, satisfaction with treatment, return rate, typanometry, referral to ENT
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/1996
Overall trial end date
01/12/2000
Reason abandoned
Eligibility
Participant inclusion criteria
240 children aged 6 months to 10 yrs with acute painful red ear.
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
240
Participant exclusion criteria
Toxicity, previous antibiotic treatment for otitis media in last 2 weeks, serious chronic disorders, complications from previous attacks
Recruitment start date
01/10/1996
Recruitment end date
01/12/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Primary Medical Care
Southampton
SO15 6ST
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South East
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2001 results in: http://www.ncbi.nlm.nih.gov/pubmed/11159657
2006 follow-up results in: http://www.ncbi.nlm.nih.gov/pubmed/16536957
Publication citations
-
Results
Little P, Gould C, Williamson I, Moore M, Warner G, Dunleavey J, Pragmatic randomised controlled trial of two prescribing strategies for childhood acute otitis media., BMJ, 2001, 322, 7282, 336-342.
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Little P, Moore M, Warner G, Dunleavy J, Williamson I, Longer term outcomes from a randomised trial of prescribing strategies in otitis media., Br J Gen Pract, 2006, 56, 524, 176-182.