CoughNCT00353951
An Observational Study of Cough / Lower Respiratory Tract Infection (LRTI) in Primary Care
An observational study of Cough and Lower Respiratory Tract Infection (LRTI), run by Cardiff University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cough, Lower Respiratory Tract Infection (LRTI), Chest Infection
- How many people
- 3,402 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2006to Jul 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous study participants.
- Immunocompromised.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- 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.
- To identify priorities for intervention studies aimed at enhancing antibiotic prescribing for community acquired cough / chest infection and other aspects of management.
- 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.
- Keywords
- primary care, lower respiratory tract infection, antibiotics, cough
- Medical subject headings
- Cough
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2006 (estimated)
- Study startSep 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff University
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, University of Southampton, Universiteit Antwerpen, Utrecht University
- Investigators
- Christopher C Butler, FRCGP CCH MD, Principal investigator, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353951
- Sponsor's protocol ID
- GRACE-01
- Status last verified
- May 2008
- First submitted
- 18 Jul 2006
- Last updated
- 20 May 2008
- Results posted
- No
Publications
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.
PubMed 21794112Butler 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.
PubMed 21406512Stanton 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.
PubMed 20032009Butler 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.
PubMed 19549995
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00353951
- Acronym / sponsor ID
- GRACE-01
- Keywords
- primary care, lower respiratory tract infection, antibiotics, cough
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,402 participants (actual)
- Lead sponsor
- Cardiff UniversityUniversity, hospital or other
- Collaborators
- European Commission, University of Southampton, Universiteit Antwerpen, Utrecht University
- Study start
- Sep 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 19 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- To identify priorities for intervention studies aimed at enhancing antibiotic prescribing for community acquired cough / chest infection and other aspects of management.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Previous study participants.
- Immunocompromised.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2008.
- Derived from this study: PubMed 21794112Nuttall 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.
- Derived from this study: PubMed 21406512Butler 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.
- Derived from this study: PubMed 20032009Stanton 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.
- Derived from this study: PubMed 19549995Butler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher C Butler, FRCGP CCH MD principal investigator
Cardiff University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough and Lower Respiratory Tract Infection (LRTI), run by Cardiff University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00353951, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2008.