Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 22, 2012
March 23, 2012
January 2008
January 2011   (final data collection date for primary outcome measure)
all cause mortality [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01563315 on ClinicalTrials.gov Archive Site
Re-admission to hospital [ Time Frame: One month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Community-acquired Pneumonia in Buskerud County in Norway
Community-acquired Pneumonia: A Prospective Observational Study to Explore Etiology, Risk Factors and Potential Predictors for re- Admittance to Hospital and All-cause Mortality

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Probability Sample

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.

  • Community-Acquired Infections
  • Pneumonia
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
January 2012
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01563315
REK:S-06266a
Yes
Vestre Viken Hospital Trust
Vestre Viken Hospital Trust
  • Vestre Viken HF - Buskerud Hospital
  • Oslo University Hospital HF - Rikshospitalet
  • UMass Medical school, Massachusetts - USA
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
Vestre Viken Hospital Trust
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP