Clinical trial NCT01563315: Community-acquired Pneumonia in Buskerud County in Norway
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community-Acquired Infections
Pneumonia
Keywords: Community-Acquired Infections
Pneumonia/microbiology
Pneumonia/diagnosis
Prognosis
Prospective Studies
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: Vestre Viken HF - Buskerud Hospital
name: Oslo University Hospital
name: UMass Medical school, Massachusetts - USA
First posted: 2012-03-26
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: all cause mortality
timeFrame: one year
Secondary outcomes:
measure: Re-admission to hospital
timeFrame: One month
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Vestre Viken Hospital Trust
state: Buskerud
Study officials:
affiliation: Vestre Viken Hospital Trust and Oslo University Hospital
name: Lars Heggelund, MD, PhD
role: STUDY_DIRECTOR
affiliation: Vestre Viken Hospital Trust
name: Einar Husebye, MD, PhD
role: STUDY_CHAIR
affiliation: Vestre Viken Hospital Trust
name: Jan C Holter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holter JC, Muller F, Bjorang O, Samdal HH, Marthinsen JB, Jenum PA, Ueland T, Froland SS, Aukrust P, Husebye E, Heggelund L. Etiology of community-acquired pneumonia and diagnostic yields of microbiological methods: a 3-year prospective study in Norway. BMC Infect Dis. 2015 Feb 15;15:64. doi: 10.1186/s12879-015-0803-5.