Community-acquired Pneumonia in Buskerud County in Norway

Pneumonia Clinical Trial

Official title:

Community-acquired Pneumonia: A Prospective Observational Study to Explore Etiology, Risk Factors and Potential Predictors for re- Admittance to Hospital and All-cause Mortality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563315
• Other study ID #: REK:S-06266a
• Status: Completed
• Phase: N/A
• First received: March 22, 2012
• Last updated: March 23, 2012
• Start date: January 2008
• Est. completion date: January 2012

Study information

• Verified date: March 2012
• Source: Vestre Viken Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the etiology of community-acquired pneumonia, to assess risk factors and to investigate potential prognostic biomarkers of serious disease and fatal outcome.

Description:

Background: This project addresses an important challenge in international medicine: Pneumonia as the leading cause of death from infection in developed countries. Purpose: (A) Determine the etiology of CAP among adult hospitalized patients- especially the occurrence of mixed infections- by systematic implementation of combined conventional and new diagnostic methods. (B) Assess risk factors of CAP, such as COPD, congestive heart failure, smoking, malignancy etc., predictive of re-admittance to hospital and mortality. (C) Examine the prognostic value of potential predictors in relation to all-cause mortality in adult patients hospitalized with CAP. Design: Prospective observational study with inclusion of 270 adult patients during a 3-year period, who all required admission for pneumonia in a community hospital setting. Clinical and biochemical data was recorded longitudinally by inclusion, at stable clinical situation and after 6 weeks, and mortality and need for re-admission within 12 months. Patients were examined systematically, using modern research methods to explore relevant microbes. At all points, blood tests were sampled for clinical-chemical analysis, DNA, RNA and immunological analyses. Application: A translational research approach with the ambitions to elucidate new pathogenic mechanisms which could lead to new diagnostic tools and treatment modalities. This will possibly lead to less drug exposure and unnecessary hospitalization both of which have positive consequences for patients and medical care costs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• New infiltrate on chest X-ray and

• Fever > 38,0 by rectal measurement

• at least one of these additional criteria: Cough +/- expectoration, dyspnoea, respiratory chest pain, crackles or reduced respiratory sounds.

• Criteria must be present within 48 hours after admission

Exclusion Criteria:

• Patients < 18 years

• Non infectious cause of lung infiltration (tumors, embolism)

• Bronchial obstruction (tumor, bronchiectasia)

• Hospitalised more than 48 hours or discharged within the last 2 weeks

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Community-Acquired Infections
• Pneumonia

Locations

Country	Name	City	State
Norway	Vestre Viken Hospital Trust	Drammen	Buskerud

Sponsors (4)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust	Oslo University Hospital HF - Rikshospitalet, UMass Medical school, Massachusetts - USA, Vestre Viken HF - Buskerud Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		one year	No
Secondary	Re-admission to hospital		One month	No