A study to assess novel approaches to antibiotic prescription for sore throat

ISRCTN	ISRCTN86621457
DOI	https://doi.org/10.1186/ISRCTN86621457
Protocol serial number	T2.50.93
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive South West (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Little
Scientific

University of Southampton
Aldermoor Health Centre
Southampton
SO16 5ST
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To evaluate three pragmatic treatment options currently in use in the general practice management of sore throat, which will incorporate a patient centred advice package developed during the project. This will be addressed in three phases: Phase 1 - to assess the concerns of the patients presenting with sore throat, and develop standard advice which addresses these concerns Phase 2 - to assess the acceptability, symptom control and complications of three different approaches to prescribing in sore throat. Phase 3 (principal aim) - to assess the long term outcome (patient worries, surgery attendance, antibiotic prescription, complications) of the three approaches to prescribing.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Infection and infestations: Common cold
Intervention	1. Antibiotics and instructions to finish courses (Penicillin V or Erythromycin) 2. Advice alone (re symptom control/antibiotic efficacy/natural history/patient concerns) 3. Advice plus offering the patient choice of whether to have antibiotics or not
Intervention type	Other
Primary outcome measure(s)	Duration of symptoms, satisfaction and compliance
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/08/1996

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	3714
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/02/1994
Date of final enrolment	31/08/1996

University of Southampton

Southampton
SO16 5ST
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	08/03/1997		Yes	No