Community-acquired Pneumonia in Buskerud County in Norway

NCT ID: NCT01563315

Last Updated: 2012-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-01-31

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.

Conditions

Community-Acquired Infections; Pneumonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vestre Viken HF - Buskerud Hospital

UNKNOWN

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: collaborator

UMass Medical school, Massachusetts - USA

UNKNOWN

Sponsor Role: collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lars Heggelund, MD, PhD

Role: STUDY_DIRECTOR

Vestre Viken Hospital Trust and Oslo University Hospital

Einar Husebye, MD, PhD

Role: STUDY_CHAIR

Vestre Viken Hospital Trust

Jan C Holter, MD

Role: PRINCIPAL_INVESTIGATOR

Vestre Viken Hospital Trust

Locations

Vestre Viken Hospital Trust

Drammen, Buskerud, Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 25887603 (View on PubMed)

Other Identifiers

REK:S-06266a

Identifier Type: -

Identifier Source: org_study_id