Low-dose CT for Diagnosis of Pneumonia in COPD Exacerbati... | NCT02264483

Studies
Low-dose CT for Diagnosis of Pneumonia in COPD Exacerbations and Comparison of the Inflammatory Profile.

NCT02264483

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status

Unknown status

Last Update Posted

Aug 31, 2015Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

COPD Exacerbation

Interventions

Not provided

Countries

Spain

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

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Apr 2016Estimated

Completion Date

Jun 2016Estimated

First Submitted Date

Sep 12, 2014

First Submission Date that Met QC Criteria

Oct 9, 2014

First Posted Date

Oct 15, 2014Estimated

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

Aug 28, 2015

Last Update Posted Date

Aug 31, 2015Estimated

Name	Class
Sociedad Española de Neumología y Cirugía Torácica	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

* Hypothesis: There is an underdiagnosis of pneumonia in COPD (Chronic Obstructive Pulmonary Disease) exacerbations which could be demonstrated by performing low-dose chest CT. Differences in the inflammatory profile in sputum and blood in patients with and without pneumonia can be seen.

* Objective: To assess the degree of underdiagnosis of pneumonia in COPD exacerbations, using chest low-dose CT and to compare clinical and inflammatory differences in blood and sputum between patients with and without pneumonia.

*Material and Methods: Prospective observational study including 75 patients with the diagnosis of COPD at the time of an exacerbation and with criteria for a respiratory tract infection. At the time of inclusion clinical features, blood and sputum analysis, chest X-ray and chest low-dose CT are performed. The investigators divide the patients into two groups according to the existence of pneumonia and the inflammatory pattern in blood (inflammatory markers) and sputum (cell populations and inflammatory markers) is compared between the two branches.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COPD exacerbation		No intervention. The subjects will be divided in 2 subgroups according to the image study: COPD exacerbation with pneumonia COPD exacerbation without pneumonia
COPD stable patients

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with an exacerbation of their disease who have a Pneumonia diagnosed by low dose - CT (not detected by chest X-Ray).		1 year and a half

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA

clinical and spirometric diagnosis of COPD.
for study group: clinical symptoms of exacerbation and infection of low airway.
Signed informed consent.

EXCLUSION CRITERIA

No acceptance of informed consent.
The STUDY GROUP: treatment with antibiotic more tan 2 days before consultation.
Another entity known pulmonology other than COPD (non-obstructive disorders, bronchiectasis, interstitial lung disease patients, severe pulmonary hypertension, hypoventilation).
Chronic treatment with oral corticosteroids or immunosuppressive drug.
severe organ comorbidity such as cancer in advanced or terminal phase, pulmonary tuberculosis with important involvement, severe pneumoconiosis.
Severe alteration of nutritional status.
Heart disease evolved.
Limitation for understanding the study (including psychiatric disorder, language problem, social or cultural differences, etc.).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

COPD patients with an exacerbation of their disease and symptoms of respiratory infection, wich come to visit at outpatient pneumologic clinic.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laura Sebastian	Contact			lsebastian@santpau.cat

Overall Officials

Name	Affiliation	Role
Ingrid Solanes, MD PhD	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de la Santa Creu i Sant Pau	Recruiting	Barcelona	Barcelona	08041	Spain