Viral Infections in Chronic Obstructive Pulmonary Disease... | NCT00448604

Studies
Viral Infections in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

NCT00448604

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

Nov 4, 2010Estimated

Enrollment

86Actual

Phase

Not provided

Conditions

Pulmonary Disease, Chronic Obstructive
Respiratory Tract Infections
Virus Diseases
Lung Diseases, Obstructive

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Mar 16, 2007

First Submission Date that Met QC Criteria

Mar 16, 2007

First Posted Date

Mar 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2010

Last Update Posted Date

Nov 4, 2010Estimated

Name	Class
Ligue Pulmonaire Genevoise	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objectives of the study are

to determine the prevalence of respiratory virus infections in COPD patients, during and outside acute exacerbation
to explore the impact of these viral infections on the outcome of these patients
to explore the association between blood procalcitonin levels and viral infections in this population.

Detailed Description

Background

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity due to repeated exacerbations. The impact of viral infections during and outside COPD exacerbations is poorly understood and there is only scarce data on the role of new biological markers of infection for the management of COPD exacerbations.

Objectives of the project

The investigators aim to

describe the epidemiology of viral infections in patients admitted with an exacerbation of their COPD;
explore the evolution of viral infections outside exacerbations;
analyze the impact of viral infections on clinical outcomes;
explore the role of biological markers (CRP, procalcitonin) for the diagnosis and prognosis of viral infections.

Methods

The investigators will prospectively follow-up 100 patients admitted with an acute exacerbation of their COPD. Virological samples will be obtained at admission and at 3 months, to explore the evolution outside episodes of acute exacerbation. Clinical information will be obtained after one-year follow-up. Samples will be tested by RT-PCR for 15 respiratory viruses. The impact of viral infections and the role of biological markers will be explored using univariate and multivariate Cox proportional hazard models.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

86Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All consecutive patients known or suspected for moderate to very severe COPD and admitted in the emergency center for an acute exacerbation of their COPD
Age above 18 years
We plan to include 100 patients with a complete work-up and follow-up
Written informed consent will be obtained from every participant

Exclusion Criteria:

Patients requiring oro-tracheal intubation
Patients unable to give their informed consent due to their clinical condition
Other obvious cause of dyspnea (pulmonary embolism, acute pulmonary edema, lobar pneumonia)
Patients suffering from bronchiectasis, asthma, pulmonary fibrosis and mineral dust pneumoconiosis
Patients with a history of active tuberculosis
Patients with a history of ischemic cerebral stroke and subsequent deglutition dysfunction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with COPD admitted with acute exacerbation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olivier T Rutschmann, MD, MPH	University Hospital, Geneva	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Geneva University Hospital		Geneva	Canton of Geneva	1211	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20435659	Derived	Kherad O, Kaiser L, Bridevaux PO, Sarasin F, Thomas Y, Janssens JP, Rutschmann OT. Upper-respiratory viral infection, biomarkers, and COPD exacerbations. Chest. 2010 Oct;138(4):896-904. doi: 10.1378/chest.09-2225. Epub 2010 Apr 30.

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D012141	Respiratory Tract Infections
D014777	Virus Diseases
D008173	Lung Diseases, Obstructive