Trial document




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  DRKS00009831

Trial Description

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Title

Legionella in drinking water plumbing systems - Analysis of drinking water investigations and epidemiological case-control study

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Trial Acronym

LeTriWa

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URL of the Trial

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Brief Summary in Lay Language

In Germany, Legionella spp. belong to the most important causative agents of community-acquired pneumonia. An estimated number of 15,000–30,000 Legionnaires’ disease (LD) cases occur each year and about 6 to 10 % of those die. Despite this considerable disease burden, the vast majority of LD cases is not recognized. Furthermore, it is difficult to identify the source of infection. Despite the fact that drinking water quality is assumed to be related to the acquisition of LD, there are still uncertainties about the exact associations. This study examines the risk factors for community-acquired LD with focus on the risks caused by domestic drinking water plumbing systems. In the framework of a case-control study, about 150 patients with laboratory-confirmed community-acquired Legionella infection from the federal states of Berlin and Brandenburg will be recruited. Two controls from the base population will be assigned to each case. Retrospectively, both groups (cases and controls) will be compared with respect to certain factors that are assumed to be associated with the acquisition of LD. By use of statistical methods, it will be estimated in how far the water plumbing systems but also personal traits, behaviors and characteristics of different Legionella strains contribute to LD acquisition. Furthermore, this study aims to estimate how frequently pneumonias are caused by Legionella and how frequently the source of Legionella infection can be identified by detailed interviews and diagnostics.

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Brief Summary in Scientific Language

Background: In Germany, Legionella spp. belong to the most important causative agents of (sporadic) community-acquired pneumonia (“community-acquired Legionnaires’ disease”, CALD [in contrast to travel-associated or nosocomial infections]). An estimated number of 15,000–30,000 CALD-cases occur each year with a case fatality rate of about 6–10 %. Despite the considerable public health relevance and the fact that Legionella infection is notifiable according to the German Communicable Diseases Law Reform Act, the vast majority of CALD-cases is not diagnosed or not reported, respectively. In 2015, merely 873 Legionella infections were reported (not only CALD but all kinds of Legionella infections). Furthermore, it is difficult to identify the source of infection. Internationally, studies showed a source attribution rate of less than 5 %. Despite the fact that drinking water quality is assumed to be related to the acquisition of CALD there are still uncertainties about the exact associations that will be focused in this study. Methods: In the framework of a case-control study (2016–2019) about 150 adult CALD-cases will be recruited in the German federal states of Berlin and Brandenburg. Two controls (individuals without CALD) that will be matched for age (5-year age-groups), sex, smoking status, comorbidities and city district) will be assigned to each case. Retrospectively, both groups (cases and controls) will be compared with respect to factors that are suspected to be associated with CALD acquisition. Among other things, multivariable logistic regression models will be applied to estimate in how far certain personal characteristics (e.g. education, profession) and behaviors (e.g. showering habits) contribute to CALD acquisition. Additionally, also environmental factors – particularly with respect to drinking water quality – (e.g. technical attributes of the domestic drinking water plumbing systems, Legionella concentration in drinking water) and characteristics of different Legionella strains will be investigated. Furthermore, this study aims to estimate how frequently community-acquired pneumonias are caused by Legionella and how frequently the case-specific source of infection can be identified by detailed interviews and microbiological and molecular biological diagnostics. Public Health relevance: The high number of estimated CALD-cases as well as the fact that Legionella spp. can be found almost ubiquitously in water sources underlines the public health relevance. Increasing CALD-awareness and accurate diagnostics and reporting as well as detailed knowledge of the CALD risk factors enable effective disease prevention benefitting a large share of the population.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00009831
  •   2016/06/07
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  •   yes
  •   Approved
  •   EA1/303/15, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   A48.1 -  Legionnaires disease
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Interventions/Observational Groups

  •   In this case-control study, patients with Legionnaires disease (cases) will be compared to patients without the disease (hospital controls), matched for age (5-years age groups), sex, smoking status, and city district. For this purpose, a standardized questionnaire is used examining potential risk factors for the acquisition of Legionella infection.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Determination of risk factors for sporadic community-acquired Legionnaires‘ disease and the estimation of their independent effect sizes, particularly with respect to possible causes of disease in domestic drinking water supply.

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Secondary Outcome

(1) Estimation how frequently community-acquired pneumonias are caused by Legionella spp.
(2) Estimation how frequently the case-specific source of infection can be identified by detailed interviews and microbiological and molecular biological diagnostics.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2016/07/15
  •   450
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Cases: (1) sporadic community-acquired Legionnaires' disease (laboratory confirmed), (2) residence in Berlin or Brandenburg (Germany), (3) full-aged, (4) able to give an informed consent, (5) informed consent given (if cases are ventilated, next of kin will be interviewed); Controls: (1) matched for age (in 5-year age-groups), sex, smoking status, comorbidities, and residence, (2) able to give an informed consent, (3) informed consent given

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Exclusion Criteria

Cases: (1) if it is likely that the Legionnaires‘ disease is associated with travel or a stay in a hospital, (2) informed consent not given; Controls: (1) acute or chronic respiratory disease, (2) informed consent not given

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Addresses

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    • Robert Koch-Institut, Abteilung 3 "Infektionsepidemiologie", Fachgebiet 36 "Respiratorisch übertragbare Erkrankungen"
    • Mr.  Prof. Dr.  Walter  Haas 
    • Seestraße 10
    • 13353  Berlin
    • Germany
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    • Umweltbundesamt
    • Bad Elster
    • Germany
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    • Konsiliarlabor für Legionellen
    • Dresden
    • Germany
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    • Robert Koch-Institut, Abteilung 3 "Infektionsepidemiologie", Fachgebiet 36 "Respiratorisch übertragbare Erkrankungen"
    • Mr.  Dr.  Heiko  Jahn 
    • Seestraße 10
    • 13302  Berlin
    • Germany
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    • Robert Koch-Institut, Abteilung 3 "Infektionsepidemiologie", Fachgebiet 36 "Respiratorisch übertragbare Erkrankungen"
    • Mr.  Dr.  Heiko  Jahn 
    • Seestraße 10 /650261
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit
    • 53121  Bonn
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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