An Observational Study of Cough / Lower Respiratory Tract Infection (LRTI) in Primary Care
NCT ID: NCT00353951
Last Updated: 2008-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3402 participants
OBSERVATIONAL
2006-09-30
2007-07-31
Brief Summary
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Grace-01 is the first study to be undertaken as part of GRACE and the aims of this study are to describe the presentation, diagnosis, investigation, management and outcomes for people with cough / chest infection in general medical practice in 13 primary care networks in 12 countries in Europe.
Detailed Description
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The first study undertaken as part of GRACE is GRACE-01, an observational study, which aims to describe the presentation, management (evaluation and treatment decisions) and outcomes for people with cough / chest infection in general medical practice in 13 primary care networks in Europe. This will be an observational study of current practice involving no experimental procedures or interventions.
Other objectives Of GRACE-01 are:
1. To describe variation in management of cough / chest infection including antibiotic prescribing in primary care between, and within, selected European countries in order to explain how good practice could be made explicit and generalised.
2. To identify priorities for intervention studies aimed at enhancing antibiotic prescribing for community acquired cough / chest infection and other aspects of management.
3. To contribute to developing interventions aimed at enhancing antibiotic prescribing and other aspects of management of community-acquired cough / chest infection that are applicable across the European Union (EU), and also to interventions that are relevant to unique local situations within Europe.
There will be two recruitment periods, one beginning on the second of October 2006 or soon thereafter and a second beginning on the first of February 2007 or soon thereafter. The goal is for each of the 13 participating European networks to recruit a total of 150 patients during each of these recruitment periods.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* With acute or worsened cough with a duration of up to and including 28 days, or a clinical presentation that suggests a lower respiratory tract infection.
* Consulting for the first time within this illness episode.
* Seen within normal consulting hours.
* Able to fill out study materials.
* Who have provided written, informed consent to participate.
Exclusion Criteria
* Immunocompromised.
18 Years
ALL
No
Sponsors
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European Commission
OTHER
University of Southampton
OTHER
Universiteit Antwerpen
OTHER
Utrecht University
OTHER
Cardiff University
OTHER
Principal Investigators
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Christopher C Butler, FRCGP CCH MD
Role: PRINCIPAL_INVESTIGATOR
Cardiff University
Locations
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GRACE Network in Cardiff
Cardiff, , United Kingdom
Countries
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References
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Nuttall J, Hood K, Verheij TJ, Little P, Brugman C, Veen RE, Goossens H, Butler CC. Building an international network for a primary care research program: reflections on challenges and solutions in the set-up and delivery of a prospective observational study of acute cough in 13 European countries. BMC Fam Pract. 2011 Jul 27;12:78. doi: 10.1186/1471-2296-12-78.
Butler CC, Kelly MJ, Hood K, Schaberg T, Melbye H, Serra-Prat M, Blasi F, Little P, Verheij T, Molstad S, Godycki-Cwirko M, Edwards P, Almirall J, Torres A, Rautakorpi UM, Nuttall J, Goossens H, Coenen S. Antibiotic prescribing for discoloured sputum in acute cough/lower respiratory tract infection. Eur Respir J. 2011 Jul;38(1):119-25. doi: 10.1183/09031936.00133910. Epub 2011 Mar 15.
Stanton N, Hood K, Kelly MJ, Nuttall J, Gillespie D, Verheij T, Little P, Godycki-Cwirko M, Goossens H, Butler CC. Are smokers with acute cough in primary care prescribed antibiotics more often, and to what benefit? An observational study in 13 European countries. Eur Respir J. 2010 Apr;35(4):761-7. doi: 10.1183/09031936.00168409. Epub 2009 Dec 23.
Butler CC, Hood K, Verheij T, Little P, Melbye H, Nuttall J, Kelly MJ, Molstad S, Godycki-Cwirko M, Almirall J, Torres A, Gillespie D, Rautakorpi U, Coenen S, Goossens H. Variation in antibiotic prescribing and its impact on recovery in patients with acute cough in primary care: prospective study in 13 countries. BMJ. 2009 Jun 23;338:b2242. doi: 10.1136/bmj.b2242.
Other Identifiers
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GRACE-01
Identifier Type: -
Identifier Source: org_study_id