Nosocomial and Community Acquired Legionella Pneumophila Pneumonia.

July 19, 2022 updated by: Dr Philippe CLEVENBERGH

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

Completed

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brussel, Belgium, 1020
        • CHU Brugmann
      • Brussels, Belgium, 1650
        • CHU St Pierre Hospital
      • Brussels, Belgium
        • Universitair Zienkenhuis Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All confirmed human cases of Legionnaires' disease diagnosed within the CHU Brugmann hospital, the St Pierre Hospital and the UZ Brussel Hospital. The definition of Legionnaires' disease diagnosis is met whether a seroconversion is detected or positive respiratory samples cultures are objectivized or positive LUA are observed. Seroconversion is defined as a rising of Legionella antibodies, dilution superior to 1/128 by indirect immunofluorescence. Nosocomial cases of Legionnaires' disease are defined in this study as the ones having an onset of symptoms more than 10 days after hospitalization.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Data extraction from medical files

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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marco Moretti, MD, CHU Brugmann

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2019

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 26, 2019

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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