Community-acquired Pneumonia in Buskerud County in Norway
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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 |
- all cause mortality [ Time Frame: one year ] [ Designated as safety issue: No ]
- 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 |
|---|
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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.
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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 |
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.
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| Norway | |
| Vestre Viken Hospital Trust | |
| Drammen, Buskerud, Norway, 3004 | |
| 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 May 23, 2013