Community-Acquired InfectionsNCT01563315
Community-acquired Pneumonia in Buskerud County in Norway
An observational study of Community-Acquired Infections and Pneumonia, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-Acquired Infections, Pneumonia
- How many people
- 270 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2008to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Keywords
- Community-Acquired Infections, Pneumonia/microbiology, Pneumonia/diagnosis, Prognosis, Prospective Studies
- Medical subject headings
- Community-Acquired Infections, Pneumonia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: one year
Secondary outcomes (1)
Re-admission to hospital
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startJan 2008
- Primary completionJan 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community-Acquired InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Vestre Viken HF - Buskerud Hospital, Oslo University Hospital, UMass Medical school, Massachusetts - USA
- Responsible party
- Sponsor
- Investigators
- Lars Heggelund, MD, PhD, Study director, Vestre Viken Hospital Trust and Oslo University HospitalEinar Husebye, MD, PhD, Study chair, Vestre Viken Hospital TrustJan C Holter, MD, Principal investigator, Vestre Viken Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563315
- Sponsor's protocol ID
- REK:S-06266a
- Status last verified
- Mar 2012
- First submitted
- 22 Mar 2012
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25887603
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01563315
- Acronym / sponsor ID
- REK:S-06266a
- Conditions
- Community-Acquired Infections, Pneumonia
- Keywords
- Community-Acquired Infections, Pneumonia/microbiology, Pneumonia/diagnosis, Prognosis, Prospective Studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- Vestre Viken HF - Buskerud Hospital, Oslo University Hospital, UMass Medical school, Massachusetts - USA
- Study start
- Jan 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- New infiltrate on chest X-ray and
- Fever > 38,0 by rectal measurement
- Criteria must be present within 48 hours after admission
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all cause mortality
Time frame: one year
1 secondary outcome
Re-admission to hospital
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
- Derived from this study: PubMed 25887603Holter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Heggelund, MD, PhD study director
Vestre Viken Hospital Trust and Oslo University Hospital
Einar Husebye, MD, PhD study chair
Vestre Viken Hospital Trust
Jan C Holter, MD principal investigator
Vestre Viken Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-Acquired Infections and Pneumonia, run by Vestre Viken Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01563315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.