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Completed

NCT Number: NCT04106037

Nosocomial and Community Acquired Legionella Pneumophila Pneumonia.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data extraction from medical files

Other

Data extraction from medical files

Primary outcomes

  1. All cause mortality

    Time frame: 3 years

    All cause mortality

  2. Severity respiratory failure

    Time frame: 3 years

    Arterial pression of oxygen inferior to 600mmHg at diagnosis

Secondary outcomes

  1. Age

    Time frame: One day

    Age at diagnosis

  2. Sex

    Time frame: One day

    Sex

  3. 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.

  4. Smoking status

    Time frame: One day

    Smoking (yes/no) at diagnosis

  5. 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.

  6. C reactive protein

    Time frame: One day

    C reactive protein level at diagnosis

  7. White blood cells

    Time frame: One day

    White blood cells level at diagnosis

  8. Creatinine

    Time frame: One day

    Creatinine level at diagnosis

  9. Urea

    Time frame: One day

    Urea level at diagnosis

  10. Chest X Ray

    Time frame: One day

    Descriptive analysis of Chest X Ray findings at diagnosis

  11. Method of diagnosis

    Time frame: One day

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

  12. Intensive care unit hospitalization

    Time frame: One day

    Intensive care unit hospitalization (yes/no)

  13. Antibiotics

    Time frame: One day

    Name of antibiotics given

  14. Antibiotic treatment duration

    Time frame: up to 40 days

    Antibiotic treatment duration

Sponsors and collaborators

Lead sponsor

Dr Philippe CLEVENBERGH

Other

Registry information

Official study title

Nosocomial and Community Acquired Legionella Pneumophila Pneumonia, a Retrospective Case Series

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 26, 2019
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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