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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
DOI 10.1186/ISRCTN99871214
ClinicalTrials.gov identifier
EudraCT number
Public title Genomics to combat Resistance against Antibiotics for Community acquired lower respiratory tract infection (LRTI) in Europe: INternet Training for Reducing antibiOtic use trial
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
Acronym GRACE INTRO
Serial number at source 8156
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Southampton and South West Hampshire Research Ethics Committee A, 13/05/2010, ref: 10/H0502/29
Study design Multicentre randomised interventional process of care trial
Countries of recruitment Belgium, Netherlands, Poland, Spain, United Kingdom
Disease/condition/study domain Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
Participants - 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
Participants - exclusion criteria Patients who are unable to properly consent or fill out the diary (dementia, psychosis, severe depression)
Anticipated start date 01/10/2010
Anticipated end date 01/05/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Planned sample size: 19600; UK sample size: 4900
Interventions 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
Primary outcome measure(s) Antibiotic prescribing, measured at baseline and after intervention
Secondary outcome measure(s) 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
Sources of funding European Commission (Belgium) - The Sixth Framework Programme (FP6) (ref: LSHM-CT-2005-518226)
Trial website https://www.grace-lrti.org/portal/en-GB
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23915885
Contact name Dr  Gillian  O'Reilly
  Address Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
  City/town Southampton
  Zip/Postcode SO16 5ST
  Country United Kingdom
  Email gor@soton.ac.uk
Sponsor University of Southampton (UK)
  Address Clinical Neurosciences Division
Memory Assessment and Research Centre
Moorgreen Hospital
Botley Road
  City/town Southampton
  Zip/Postcode SO30 3JB
  Country United Kingdom
  Sponsor website: http://www.soton.ac.uk/
Date applied 07/07/2010
Last edited 14/07/2014
Date ISRCTN assigned 07/07/2010
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