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

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ClinicalTrials.gov Identifier: NCT00353951
Recruitment Status : Completed
First Posted : July 19, 2006
Last Update Posted : May 20, 2008
Sponsor:
Collaborators:
European Commission
University of Southampton
Universiteit Antwerpen
Utrecht University
Information provided by:
Cardiff University

Brief Summary:

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.


Condition or disease
Cough Lower Respiratory Tract Infection (LRTI) Chest Infection

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 3402 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : September 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353951


Locations
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United Kingdom
GRACE Network in Cardiff
Cardiff, United Kingdom, CF5 4AD
Sponsors and Collaborators
Cardiff University
European Commission
University of Southampton
Universiteit Antwerpen
Utrecht University
Investigators
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Principal Investigator: Christopher C Butler, FRCGP CCH MD Cardiff University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00353951     History of Changes
Other Study ID Numbers: GRACE-01
First Posted: July 19, 2006    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008

Keywords provided by Cardiff University:
primary care
lower respiratory tract infection
antibiotics
cough

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Cough
Respiratory Tract Infections
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms