- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04106037
Nosocomial and Community Acquired Legionella Pneumophila Pneumonia.
Nosocomial and Community Acquired Legionella Pneumophila Pneumonia, a Retrospective Case Series
Legionnaire's disease (LD) is a major cause of both community acquired and nosocomial pneumonia, with Legionella pneumophila serogroup A (Lp1) being the most virulent and the greatest cause of disease. Sample culture of low respiratory tract is considered the gold standard in the diagnosis of LD, however its sensitivity seems to be poor and its performance is technically demanding. The introduction of urinary antigen detection testing (LUA) brought a major advance in LD diagnosis, with upt to 95% of cases in Europe being diagnosed with this method. Despite the high sensitivity of LUA for Lp1, ranging from 80-90%, its negative predictive value is low in other serogroup than Lp1 and therefore, Legionella may be unrecognized as agent of pneumonia. Although underdiagnosed and underreported, LD represents the second most common cause of pneumonia requiring admission in intensive care unit (ICU). Average fatality rate of LD in Europe reaches 10%, but its mortality is considered to be even higher in nosocomial patients.
Despite the higher fatality rate in hospitalized LD patients, poor is the knowledge on the risk factors that could induce disease and that increase mortality in the hospitalized population affected by LD. In order to shed more light on this topic a cohort of patients diagnosed with LD in the last 3 years will be retrospectively examined.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Brussel, Belgium, 1020
- CHU Brugmann
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Brussels, Belgium, 1650
- CHU St Pierre Hospital
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Brussels, Belgium
- Universitair Zienkenhuis Brussel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
All confirmed human cases of Legionnaires' disease diagnosed within the CHU Brugmann hospital within the last 3 years, from 01/01/2016 till 31/12/2018. A similar approach will be followed for the St Pierre and the UZ Brussel Hospitals.
Exclusion Criteria:
Pregnant women.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Legionnaires' disease
All confirmed human cases of Legionnaires' disease diagnosed within the CHU Brugmann hospital within the last 3 years: from 01/01/2016 till 31/12/2018.
A similar approach will be followed for the St Pierre Hospital and the UZ Brussel Hospital.
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Data extraction from medical files
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All cause mortality
Time Frame: 3 years
|
All cause mortality
|
3 years
|
Severity respiratory failure
Time Frame: 3 years
|
Arterial pression of oxygen inferior to 600mmHg at diagnosis
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age
Time Frame: One day
|
Age at diagnosis
|
One day
|
Sex
Time Frame: One day
|
Sex
|
One day
|
Charlson comorbidity index
Time Frame: One day
|
This is a health tool that assesses the comorbidity risk associated to a series of conditions in order to offer medical specialists an informed decision making process in terms of specific screenings or medical procedures.The index accounts for the patient age and 16 different conditions, and ranges from 0 till 37.
|
One day
|
Smoking status
Time Frame: One day
|
Smoking (yes/no) at diagnosis
|
One day
|
Nosocomial disease (yes/no)
Time Frame: One day
|
Nosocomial cases of Legionnaires' disease are defined in this study as having an onset of symptoms more than 10 days after hospitalization.
|
One day
|
C reactive protein
Time Frame: One day
|
C reactive protein level at diagnosis
|
One day
|
White blood cells
Time Frame: One day
|
White blood cells level at diagnosis
|
One day
|
Creatinine
Time Frame: One day
|
Creatinine level at diagnosis
|
One day
|
Urea
Time Frame: One day
|
Urea level at diagnosis
|
One day
|
Chest X Ray
Time Frame: One day
|
Descriptive analysis of Chest X Ray findings at diagnosis
|
One day
|
Method of diagnosis
Time Frame: One day
|
Name of the method of diagnosis (urinary antigen, seroconversion, cultures).
|
One day
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Intensive care unit hospitalization
Time Frame: One day
|
Intensive care unit hospitalization (yes/no)
|
One day
|
Antibiotics
Time Frame: One day
|
Name of antibiotics given
|
One day
|
Antibiotic treatment duration
Time Frame: up to 40 days
|
Antibiotic treatment duration
|
up to 40 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marco Moretti, MD, CHU Brugmann
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUB-Moretti
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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