Community-acquired Pneumonia in Buskerud County in Norway

This study has been completed.
Sponsor:
Collaborators:
Vestre Viken HF - Buskerud Hospital
Oslo University Hospital HF - Rikshospitalet
UMass Medical school, Massachusetts - USA
Information provided by (Responsible Party):
Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier:
NCT01563315
First received: March 22, 2012
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

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.


Condition
Community-Acquired Infections
Pneumonia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Vestre Viken Hospital Trust:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Re-admission to hospital [ Time Frame: One month ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum, plasma, blood culture, airways specimens, urine


Enrollment: 270
Study Start Date: January 2008
Study Completion Date: January 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adults with CAP admitted to hospital
All adult patients with CAP admitted to Vestre Viken HF-Buskerud Hospital (VVHF-BH), a 400-bed community general hospital, between January 2008 og January 2011 were evaluated for inclusion in the study.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All adult patients with CAP admittet to Vestre Viken HF-Buskerud Hospital (VVHF-BH) between January 2008 og January 2011, were evaluated for inclusion in the study.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563315

Locations
Norway
Vestre Viken Hospital Trust
Drammen, Buskerud, Norway, 3004
Sponsors and Collaborators
Vestre Viken Hospital Trust
Vestre Viken HF - Buskerud Hospital
Oslo University Hospital HF - Rikshospitalet
UMass Medical school, Massachusetts - USA
Investigators
Study Director: Lars Heggelund, MD, PhD Vestre Viken Hospital Trust and Oslo University Hospital
Study Chair: Einar Husebye, MD, PhD Vestre Viken Hospital Trust
Principal Investigator: Jan C Holter, MD Vestre Viken Hospital Trust
  More Information

No publications provided

Responsible Party: Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier: NCT01563315     History of Changes
Other Study ID Numbers: REK:S-06266a
Study First Received: March 22, 2012
Last Updated: March 23, 2012
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Vestre Viken Hospital Trust:
Community-Acquired Infections
Pneumonia/microbiology
Pneumonia/diagnosis
Prognosis
Prospective Studies

Additional relevant MeSH terms:
Pneumonia
Community-Acquired Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection

ClinicalTrials.gov processed this record on April 23, 2014