NCT01563315

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2012

Completed
Last Updated

March 26, 2012

Status Verified

March 1, 2012

Enrollment Period

3 years

First QC Date

March 22, 2012

Last Update Submit

March 23, 2012

Conditions

Keywords

Community-Acquired InfectionsPneumonia/microbiologyPneumonia/diagnosisPrognosisProspective Studies

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    one year

Secondary Outcomes (1)

  • Re-admission to hospital

    One month

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestre Viken Hospital Trust

Drammen, Buskerud, 3004, Norway

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Community-Acquired InfectionsPneumoniaDisease

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lars Heggelund, MD, PhD

    Vestre Viken Hospital Trust and Oslo University Hospital

    STUDY DIRECTOR
  • Einar Husebye, MD, PhD

    Vestre Viken Hospital Trust

    STUDY CHAIR
  • Jan C Holter, MD

    Vestre Viken Hospital Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2012

First Posted

March 26, 2012

Study Start

January 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2012

Last Updated

March 26, 2012

Record last verified: 2012-03

Locations