Nosocomial and Community Acquired Legionella Pneumophila Pneumonia.

NCT04106037 | Completed

• 1 other identifier: CHUB-Moretti
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Legionnaires' Disease

Outcome Measures

Primary Outcomes (2)

• All cause mortality

  All cause mortality

  3 years

• Severity respiratory failure

  Arterial pression of oxygen inferior to 600mmHg at diagnosis

  3 years

Secondary Outcomes (14)

• Age

  One day

• Sex

  One day

• Charlson comorbidity index

  One day

• Smoking status

  One day

• Nosocomial disease (yes/no)

  One day

Study Arms (1)

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

Data extraction from medical files OTHER

Data extraction from medical files

Legionnaires' disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women.

Sponsors & Collaborators

• Dr Philippe CLEVENBERGH: lead

Study Sites (3)

CHU Brugmann

Brussels, 1020, Belgium

Location

CHU St Pierre Hospital

Brussels, 1650, Belgium

Location

Universitair Zienkenhuis Brussel

Brussels, Belgium

Location

MeSH Terms

Conditions

Legionnaires' Disease

Condition Hierarchy (Ancestors)

Legionellosis; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Marco Moretti, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Infectious Diseases Department

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 26, 2019
• Study Start: August 13, 2019
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)