NCT00353951

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,402

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

May 20, 2008

Status Verified

May 1, 2008

Enrollment Period

10 months

First QC Date

July 18, 2006

Last Update Submit

May 19, 2008

Conditions

Keywords

primary carelower respiratory tract infectionantibioticscough

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous study participants.
  • Immunocompromised.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GRACE Network in Cardiff

Cardiff, CF5 4AD, United Kingdom

Location

Related Publications (4)

  • 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.

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher C Butler, FRCGP CCH MD

    Cardiff University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 19, 2006

Study Start

September 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

May 20, 2008

Record last verified: 2008-05

Locations