Nosocomial and Community Acquired Legionella Pneumophila Pneumonia.

Legionnaires' Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04106037
• Other study ID #: CHUB-Moretti
• Status: Completed
• Start date: August 13, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2022
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Legionellosis
• Legionnaires' Disease
• Pneumonia

Intervention

Other:
• Data extraction from medical files
Data extraction from medical files

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussel
Belgium	CHU St Pierre Hospital	Brussels
Belgium	Universitair Zienkenhuis Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Dr Philippe CLEVENBERGH

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	All cause mortality	3 years
Primary	Severity respiratory failure	Arterial pression of oxygen inferior to 600mmHg at diagnosis	3 years
Secondary	Age	Age at diagnosis	One day
Secondary	Sex	Sex	One day
Secondary	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.	One day
Secondary	Smoking status	Smoking (yes/no) at diagnosis	One day
Secondary	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.	One day
Secondary	C reactive protein	C reactive protein level at diagnosis	One day
Secondary	White blood cells	White blood cells level at diagnosis	One day
Secondary	Creatinine	Creatinine level at diagnosis	One day
Secondary	Urea	Urea level at diagnosis	One day
Secondary	Chest X Ray	Descriptive analysis of Chest X Ray findings at diagnosis	One day
Secondary	Method of diagnosis	Name of the method of diagnosis (urinary antigen, seroconversion, cultures).	One day
Secondary	Intensive care unit hospitalization	Intensive care unit hospitalization (yes/no)	One day
Secondary	Antibiotics	Name of antibiotics given	One day
Secondary	Antibiotic treatment duration	Antibiotic treatment duration	up to 40 days