Sore Throat MedDRA version: 14.1 Level: PT Classification code 10001093 Term: Acute tonsillitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Dexamethasone Tablets BP 2.0mg
Product Name: Dexamethasone
Pharmaceutical Form: Capsule
INN or Proposed INN: Dexamethasone
CAS Number: 50-02-2
Concentration unit: mg milligram(s)
Concentra
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Aged 18 years or above •Presenting to a primary care appointment with acute sore throat and odynophagia (pain on swallowing) which is judged by the clinician to be infective in origin •Onset of symptoms within the last 7 days •Patient has capacity and willingness, in the view of the recruiting clinician, to give consent and complete the trial paperwork, including the Symptom Diary Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 510 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: •Female participant who is pregnant, lactating or planning pregnancy during the course of the study •Recent (<1 month) use of inhaled or oral corticosteroids. •Recent (<1 month) Adenotonsillectomy •Currently or recently (<14 days) taking antibiotics •Clear alternative diagnosis e.g. pneumonia •Known immune-deficiency (e.g. HIV, active chemotherapy or advanced cancer) •Scheduled elective surgery or other procedures requiring general anaesthesia during next 7 days •Participant who is terminally ill •Symptoms or signs suggesting that hospital admission is required (e.g. completely unable to swallow, very systemically unwell, peritonsillar abscess) •Participant judged by the GP to require immediate antibiotics •History of severe affective disorders including steroid-induced psychiatric illness •British National Formulary (BNF) listed contra-indications to oral steroids •Existing symptoms that are also side effects of, oral steroids •Patients taking other interacting medication (e.g. phenytoin and anti-coagulants). Clinicians will be asked to use the BNF and their clinical prescribing systems to check for interactions for all patients •Known dexamethasone allergy •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study •Involvement in another clinical trial of an investigational medicinal product in the last 90 days or any other research within the last 30 days •Recruiting primary care site is not the patients usual practice if the patient is not expecting to still be with the primary care site in one month (i.e. temporary residents) •Previous TOAST participation •Patients able to be randomised by the end of the (working) day of presentation •Requirement for live vaccine in next 7 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate in adults 18 years and over presenting to their GP with acute sore throat, if the use of a single dose of an oral steroid, dexamethasone, compared with no steroid treatment leads to increased resolution or improvement in symptoms.;Secondary Objective: 1) To investigate whether dexamethasone compared with a placebo leads to increased resolution or improvement in symptoms of a sore throat in those patients who have not been prescribed antibiotics 2) To investigate whether dexamethasone compared to placebo will, in those patients offered a delayed antibiotic prescription, reduce the number of patients taking antibiotics for their sore throat within 7 days 3) To investigate whether a single dose of oral dexamethasone compared to placebo will: a) reduce time away from work or education within 7 days b) not increase the incidence of hospital admission with complications related to sore throat (e.g. peritonsillar abscess) within 28 days c) not increase repeat attendance at the GP within 28 days with symptoms or complications of sore throat d) be cost-effective 4) To assess what symptoms will cause a predicted response to corticosteroids in sore throat treatment, using the FeverPAIN score, Centor score, baseline factors and posit;Primary end point(s): Direct report by the patient of presence or absence of complete resolution of sore throat at 24 hours by either text message or telephone.;Timepoint(s) of evaluation of this end point: 24hours after taking medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Direct report by those patients who have not been prescribed antibiotics of presence or absence of complete resolution of sore throat at 24 hours by either text message or telephone 2)Report of presence or absence of complete resolution of sore throat at 48 hours by either text message or telephone contact 3)Report of time to onset of pain relief (in hours) within 7 days 4)Report of time to complete symptom resolution (in hours) within 7 days 5)Duration of moderately bad symptoms recorded by validated symptom diary over the 7 days from treatment onset. 6)Severity of symptoms in the 2-4 days after seeing the doctor based on the symptom diary 7)Change in ratings of sore throat pain and pain on swallowing by visual analogue scale 8)Uptake of delayed antibiotic prescription within 7 days 9)Time missed from work or education over subsequent 7 days 10)Attendance at GP practice, A and E or Out of hours (OOH) centres within 28 days with symptoms or complications associated with sore throat e.g. peritonsillar abscess 11)Hospital admission with related complications of sore throat within 28 days 12)Use of over-the counter medications and prescription medications (including whether, if delayed antibiotics are taken, the course is completed, and whether any other antibiotics were taken) in the first 7 days 13)Cost effectiveness measures: Euroqol 5D score change in 7 days and impact on usual activities over 7 days;Timepoint(s) of evaluation of this end point: 1- 24 hours after taking medication. 2- 48 hours after taking medication. 3,4,5,6,7,8,9,10,11,12,13- Via the Symptom Diary completed daily from days 0-7 either online or on paper. 3,4,5,6,8,9,10,11,12- If necessary via a follow up questionnaire after 2 weeks, if the Symptom Diary has not been completed. 10,11,12- Through a notes review at one month at their GP practice by GP practice staff. | — |
Countries
United Kingdom
Outcome results
None listed