ClinicalTrials.gg
CompletedNCT04106037Updated Jul 20, 2022

Nosocomial and Community Acquired Legionella Pneumophila Pneumonia.

An observational study in Legionnaires' Disease, sponsored by Dr Philippe CLEVENBERGH. Completed at 3 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Dr Philippe CLEVENBERGH · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
46
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Legionnaires' Disease
03

In context

Lead sponsor

This is the only study on the registry with Dr Philippe CLEVENBERGH as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Pregnant women.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
46 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Data extraction from medical files

Interventions

  • OtherData extraction from medical files

    Data extraction from medical files

06

What researchers measure

Primary outcomes

  1. All cause mortality

    All cause mortality

    Time frame: 3 years

  2. Severity respiratory failure

    Arterial pression of oxygen inferior to 600mmHg at diagnosis

    Time frame: 3 years

Secondary outcomes

  1. Age

    Age at diagnosis

    Time frame: One day

  2. Sex

    Sex

    Time frame: One day

  3. Charlson comorbidity index

    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.

    Time frame: One day

  4. Smoking status

    Smoking (yes/no) at diagnosis

    Time frame: One day

  5. Nosocomial disease (yes/no)

    Nosocomial cases of Legionnaires' disease are defined in this study as having an onset of symptoms more than 10 days after hospitalization.

    Time frame: One day

  6. C reactive protein

    C reactive protein level at diagnosis

    Time frame: One day

  7. White blood cells

    White blood cells level at diagnosis

    Time frame: One day

  8. Creatinine

    Creatinine level at diagnosis

    Time frame: One day

  9. Urea

    Urea level at diagnosis

    Time frame: One day

  10. Chest X Ray

    Descriptive analysis of Chest X Ray findings at diagnosis

    Time frame: One day

  11. Method of diagnosis

    Name of the method of diagnosis (urinary antigen, seroconversion, cultures).

    Time frame: One day

  12. Intensive care unit hospitalization

    Intensive care unit hospitalization (yes/no)

    Time frame: One day

  13. Antibiotics

    Name of antibiotics given

    Time frame: One day

  14. Antibiotic treatment duration

    Antibiotic treatment duration

    Time frame: up to 40 days

07

Study locations

3 sites
  • CHU St Pierre Hospital
    Brussels, 1650, Belgium
  • Universitair Zienkenhuis Brussel
    Brussels, Belgium
  • CHU Brugmann
    Brussel, 1020, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2019 to primary completion in Sep 2019, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2019
First posted
Sep 26, 2019
StartActual
Aug 13, 2019
Primary completionActual
Sep 30, 2019
CompletionActual
Sep 30, 2019
Last update
Jul 20, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04106037
Lead sponsor
Dr Philippe CLEVENBERGH
Responsible party
Dr Philippe CLEVENBERGH (Head of Infectious Diseases Department, Brugmann University Hospital) — Sponsor-investigator
First posted
Sep 26, 2019
Start date
Aug 13, 2019
Primary completion
Sep 30, 2019
Completion
Sep 30, 2019
Last update
Jul 20, 2022

Study contacts

Marco Moretti, MD
principal investigator · CHU Brugmann

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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