A study to assess novel approaches to antibiotic prescription for sore throat
| ISRCTN | ISRCTN86621457 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86621457 |
| Secondary identifying numbers | T2.50.93 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 11/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - Little
Scientific
Scientific
University of Southampton
Aldermoor Health Centre
Southampton
SO16 5ST
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | Duration of symptoms, satisfaction and compliance |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/1994 |
| Completion date | 31/08/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Added December 2008: 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Southampton
Southampton
SO16 5ST
United Kingdom
SO16 5ST
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South West (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/03/1997 | Yes | No |
