Legionnaires' DiseaseNCT04106037
Nosocomial and Community Acquired Legionella Pneumophila Pneumonia.
An observational study of Legionnaires' Disease, run by Dr Philippe CLEVENBERGH at 3 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Legionnaires' Disease
- What is being tested?
- Data extraction from medical files
- How many people
- 46 participants
- Where
- 3 sitesBelgium
- Study dates
- 13 Aug 2019to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Pregnant women.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
CHU Brugmann
Brussels, 1020
CHU St Pierre Hospital
Brussels, 1650
Universitair Zienkenhuis Brussel
Brussels
About this study
Official title: 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.
- Conditions
- Legionnaires' Disease
- Being tested
- Data extraction from medical files
- Medical subject headings
- Legionnaires' Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data extraction from medical filesOther
Data extraction from medical files
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data extraction from medical files |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
All cause mortality
Measured: 3 years
Severity respiratory failure
Arterial pression of oxygen inferior to 600mmHg at diagnosis
Measured: 3 years
Secondary outcomes (14)
Age
Age at diagnosis
Measured: One day
Sex
Sex
Measured: One day
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.
Measured: One day
Smoking status
Smoking (yes/no) at diagnosis
Measured: One day
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.
Measured: One day
C reactive protein
C reactive protein level at diagnosis
Measured: One day
White blood cells
White blood cells level at diagnosis
Measured: One day
Creatinine
Creatinine level at diagnosis
Measured: One day
Urea
Urea level at diagnosis
Measured: One day
Chest X Ray
Descriptive analysis of Chest X Ray findings at diagnosis
Measured: One day
Method of diagnosis
Name of the method of diagnosis (urinary antigen, seroconversion, cultures).
Measured: One day
Intensive care unit hospitalization
Intensive care unit hospitalization (yes/no)
Measured: One day
Antibiotics
Name of antibiotics given
Measured: One day
Antibiotic treatment duration
Antibiotic treatment duration
Measured: up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start13 Aug 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Legionnaires' DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Philippe CLEVENBERGH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Philippe CLEVENBERGH, Brugmann University Hospital
- Investigators
- Marco Moretti, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106037
- Sponsor's protocol ID
- CHUB-Moretti
- Status last verified
- Jul 2022
- First submitted
- 25 Sep 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nosocomial and Community Acquired Legionella Pneumophila Pneumonia, a Retrospective Case Series
- ClinicalTrials.gov ID
- NCT04106037
- Acronym / sponsor ID
- CHUB-Moretti
- Conditions
- Legionnaires' Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Dr Philippe CLEVENBERGHUniversity, hospital or other
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Legionnaires' disease | – | Other: Data extraction from medical filesAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data extraction from medical filesData extraction from medical files | Other | Legionnaires' disease |
Primary outcome
All cause mortality
Time frame: 3 years
All cause mortality
Severity respiratory failure
Time frame: 3 years
Arterial pression of oxygen inferior to 600mmHg at diagnosis
14 secondary outcomes
Age
Time frame: One day
Sex
Time frame: One day
Charlson comorbidity index
Time frame: One day
Smoking status
Time frame: One day
Nosocomial disease (yes/no)
Time frame: One day
C reactive protein
Time frame: One day
White blood cells
Time frame: One day
Creatinine
Time frame: One day
Urea
Time frame: One day
Chest X Ray
Time frame: One day
Method of diagnosis
Time frame: One day
Intensive care unit hospitalization
Time frame: One day
Antibiotics
Time frame: One day
Antibiotic treatment duration
Time frame: up to 40 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Legionnaires' Disease
Not yet recruiting
Volatile Organic Compounds Analysis by GC-MS for Diagnostic of Hospitalised Patients With Respiratory Infections Using Exhaled Breath
Respiratory Infections, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Moretti, MD principal investigator
CHU Brugmann
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Legionnaires' Disease, run by Dr Philippe CLEVENBERGH at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.