Treatment Options without Antibiotics for Sore Throat (TOAST)

Not Applicable

Completed

• Conditions: Topic: Primary Care Research Network for England; Sore throat; Respiratory; Acute sore throat

• Registration Number: ISRCTN17435450
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-26
• Last Update Posted: 5 June 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

1. Male and female aged 18 years or above
2. 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
3. Onset of symptoms within the last 7 days
4. Patient has capacity and willingness, in the view of the recruiting clinician, to give consent and complete the trial paperwork, including the Symptom Diary

Exclusion Criteria

1. Female participant who is pregnant, lactating or planning pregnancy during the course of the study
2. Recent (<1 month) use of inhaled or oral corticosteroids
3. Recent (<1 month) Adenotonsillectomy
4. Currently or recently (<14 days) taking antibiotics
5. Clear alternative diagnosis e.g. Pneumonia
6. Known immune-deficiency (e.g. HIV, active chemotherapy or advanced cancer)
7. Scheduled elective surgery or other procedures requiring general anaesthesia during next 7 days
8. Participant who is terminally ill
9. Symptoms or signs suggesting that hospital admission is required (e.g. Completely unable to swallow, very systemically unwell, peritonsillar abscess)
10. Participant judged by the GP to require immediate antibiotics
11. History of severe affective disorders including steroid-induced psychiatric illness
12. British National Formulary (BNF) listed contra-indications to oral steroids
13. Existing symptoms that are also side effects of, oral steroids
14. 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
15. Known dexamethasone allergy
16. 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
17. Involvement in another clinical trial of an investigational medicinal product in the last 90 days or any other research within the last 30 days
18. 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)
19. Previous TOAST participation
20. Patients able to be randomised by the end of the (working) day of presentation
21. Requirement for live vaccine in next 7 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Direct report by the patient of presence or absence of complete resolution of sore throat at 24 hours by either text message or telephone