Genomics to combat Resistance against Antibiotics for Community acquired lower respiratory tract infection (LRTI) in Europe: INternet Training for Reducing antibiOtic use trial
ISRCTN | ISRCTN99871214 |
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DOI | https://doi.org/10.1186/ISRCTN99871214 |
Secondary identifying numbers | 8156 |
- Submission date
- 07/07/2010
- Registration date
- 07/07/2010
- Last edited
- 15/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gillian O'Reilly
Scientific
Scientific
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
gor@soton.ac.uk |
Study information
Study design | Multicentre randomised interventional process of care trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | GP practice |
Study type | Diagnostic |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Genomics to combat Resistance against Antibiotics for Community acquired lower respiratory tract infection (LRTI) in Europe: INternet Training for Reducing antibiOtic use - a multicentre randomised interventional process of care trial |
Study acronym | GRACE INTRO |
Study objectives | This study is part of a programme of research into cough due to chest and other infections across 15 European countries, called GRACE. This part of the GRACE study will be carried out in 6 European countries and aims to improve antibiotic prescribing for acute cough in primary care. Acute cough/lower respiratory tract infection (LRTI) is one of the commonest reasons why people seek health care and take antibiotics. The implications for use of precious health care resources and antibiotic resistance are considerable. There is a wide variation in antibiotic prescription in Europe, and based on what is known about how comparable patients are investigated and treated in different European countries, there is a need to identify educational programmes directed at clinicians and patients to determine whether they improve the management of acute cough. This study will compare antibiotic prescribing levels for practices trained via the GRACE INTRO programme (a self directed web based learning package combined with patient booklets), with those not trained, and in addition will determine whether the use of CRP tests (a test that can be performed in the surgery to help GPs decide who to give antibiotics to) are useful in targeting prescriptions to the correct patients. The aim is to see whether GP antibiotic prescribing behavior can be improved so that only those patients with chest infections that will really benefit from antibiotics are prescribed them. We will assess antibiotic use, complications and cost-effectiveness. Up to 5400 patients will take part in this study throughout Europe. |
Ethics approval(s) | Southampton and South West Hampshire Research Ethics Committee A, 13/05/2010, ref: 10/H0502/29 |
Health condition(s) or problem(s) studied | Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases |
Intervention | GP practices will be randomised into 4 intervention groups: 1. Routine care 2. Routine care plus GP training into optimal antibiotic use and patient education with booklet (INTRO Programme) 3. Routine care and additional C-reactive protein (CRP) test 4. INTRO Programme and additional CRP test Antibiotic prescribing for LRTI will be audited for the practices pre- and post-intervention over one winter season. Study entry: registration only |
Intervention type | Other |
Primary outcome measure | Antibiotic prescribing, measured at baseline and after intervention |
Secondary outcome measures | 1. Patient complications after the interventions by measuring significant deterioration of illness 2. Cost effectiveness of the interventions by measuring resource use 3. Issues behind the successes, difficulties and limitations of implementing behaviour change using GP focus groups 4. Patient perceptions of the process using patient interviews |
Overall study start date | 01/10/2010 |
Completion date | 01/05/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Planned sample size: 19600; UK sample size: 4900 |
Key inclusion criteria | 1. Aged 18 years and over, either sex 2. An illness where a acute cough or worsened cough is the main or dominant symptom, or a clinial presentation suggesting LTRI, greater than or equal to 28 days duration 3. First consultation for this illness episode 4. Seen within normal consulting hours 5. First time in this study 6. Ability to fill out study materials 7. Written consent to participate 8. Immunocompetent |
Key exclusion criteria | Patients who are unable to properly consent or fill out the diary (dementia, psychosis, severe depression) |
Date of first enrolment | 01/10/2010 |
Date of final enrolment | 01/05/2011 |
Locations
Countries of recruitment
- Belgium
- England
- Netherlands
- Poland
- Spain
- United Kingdom
Study participating centre
Primary Medical Care
Southampton
SO16 5ST
United Kingdom
SO16 5ST
United Kingdom
Sponsor information
University of Southampton (UK)
University/education
University/education
Clinical Neurosciences Division
Memory Assessment and Research Centre
Moorgreen Hospital
Botley Road
Southampton
SO30 3JB
England
United Kingdom
Website | http://www.soton.ac.uk/ |
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https://ror.org/01ryk1543 |
Funders
Funder type
Government
European Commission (Belgium) - The Sixth Framework Programme (FP6) (ref: LSHM-CT-2005-518226)
No information available
Results and Publications
Intention to publish date | |
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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 | 05/10/2013 | Yes | No | |
Results article | results | 01/03/2019 | 15/04/2020 | Yes | No |
Editorial Notes
15/04/2020: Publication reference added.