Community-acquired Pneumonia in Buskerud County in Norway

Completed

• Conditions: Community-Acquired Infections; Pneumonia

• Registration Number: NCT01563315
• Lead Sponsor: Vestre Viken Hospital Trust

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2011-01
• Study Completion: 2012-01
• Status Verified: 2012-03
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-23
• Last Update Submitted: 2012-03-23
• Study First Posted: 2012-03-26
• Last Update Posted: 2012-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all cause mortality	one year

Secondary Outcome Measures

Name	Time	Method
Re-admission to hospital	One month

Trial Locations

Locations (1)

Vestre Viken Hospital Trust; 🇳🇴 Drammen, Buskerud, Norway