Condition category
Infections and Infestations
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
11/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - Little

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

T2.50.93

Study information

Scientific title

Acronym

Study hypothesis

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

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

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

Phase

Not Specified

Drug names

Primary outcome measures

Duration of symptoms, satisfaction and compliance

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/1994

Overall trial end date

31/08/1996

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Added December 2008: 3714

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/1994

Recruitment end date

31/08/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Southampton
Southampton
SO16 5ST
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

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South West (UK)

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

1997 results on http://www.ncbi.nlm.nih.gov/pubmed/9116551

Publication citations

  1. Results

    Little P, Williamson I, Warner G, Gould C, Gantley M, Kinmonth AL, Open randomised trial of prescribing strategies in managing sore throat., BMJ, 1997, 314, 7082, 722-727.

Additional files

Editorial Notes