An Observational Study of Cough / Lower Respiratory Tract Infection (LRTI) in Primary Care

This study has been completed.
Sponsor:
Collaborators:
European Commission
University of Southampton
Universiteit Antwerpen
Utrecht University
Information provided by:
Cardiff University
ClinicalTrials.gov Identifier:
NCT00353951
First received: July 18, 2006
Last updated: May 19, 2008
Last verified: May 2008

July 18, 2006
May 19, 2008
September 2006
July 2007   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00353951 on ClinicalTrials.gov Archive Site
 
 
 
 
 
An Observational Study of Cough / Lower Respiratory Tract Infection (LRTI) in Primary Care
Genomics to Combat Resistance Against Antibiotics in Community-Acquired LRTI in Europe: GRACE. Workpackage 8. An Observational Study of Cough / Lower Respiratory Tract Infection (LRTI) in Primary Care

The overall objective of GRACE is to combat the resistance of drugs that kill bacteria and other germs (antimicrobial) through integrating centres of research excellence and using the study of the entire DNA in a cell (genomics) to most appropriately investigate and manage community-acquired LRTI.

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.

GRACE is a Network of Excellence focusing on the complex and controversial field of community-acquired lower respiratory tract infections (LRTI), which is one of the leading reasons for seeking medical care. It is funded through Funding Program 6 of the European Union. The prescription of antibiotics for LRTI accounts for a major proportion of antibiotics used in the community, and contributes to the rising prevalence of resistance among major human pathogens. The overall objective of GRACE is to combat antimicrobial resistance through integrating centres of research excellence and exploiting genomics in the investigation and management of community-acquired LRTI

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
 
 
 
  • Cough
  • Lower Respiratory Tract Infection (LRTI)
  • Chest Infection
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3402
July 2007
July 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 18 years and over.
  • 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:

  • Previous study participants.
  • Immunocompromised.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00353951
GRACE-01
 
 
Cardiff University
  • European Commission
  • University of Southampton
  • Universiteit Antwerpen
  • Utrecht University
Principal Investigator: Christopher C Butler, FRCGP CCH MD Cardiff University
Cardiff University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP