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	https://doi.org/10.1186/ISRCTN99871214
Protocol serial number	8156
Sponsor	University of Southampton (UK)
Funder	European Commission (Belgium) - The Sixth Framework Programme (FP6) (ref: LSHM-CT-2005-518226)

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

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Email	gor@soton.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre randomised interventional process of care trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Antibiotic prescribing, measured at baseline and after intervention
Key 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
Completion date	01/05/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	19600
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

United Kingdom
England
Belgium
Netherlands
Poland
Spain

Study participating centre

Primary Medical Care

Southampton
SO16 5ST
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

15/04/2020: Publication reference added.