Viewing Study NCT00353951



Ignite Creation Date: 2024-05-05 @ 4:58 PM
Last Modification Date: 2024-10-26 @ 9:26 AM
Study NCT ID: NCT00353951
Status: COMPLETED
Last Update Posted: 2008-05-20
First Post: 2006-07-18

Brief Title: An Observational Study of Cough Lower Respiratory Tract Infection LRTI in Primary Care
Sponsor: Cardiff University
Organization: Cardiff University

Study Overview

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
Status: COMPLETED
Status Verified Date: 2008-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None