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An Ecological Analysis of Nontuberculous Mycobacteria in the Geneva Area (2015-2020)

Sponsor
University Hospital, Geneva (Other)
Overall Status
Completed
CT.gov ID
NCT04718571
Collaborator
(none)
231
Enrollment
1
Location
4
Actual Duration (Months)
57.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prevalence of NTM diseases has been increasing regularly over the past 30 years in industrialized countries Although NTM are identified worldwide, there are important geographical disparities as to the relative prevalence of NTM species There are no data covering the ecology of NTM in Switzerland. Because of the progressive increase in NTM clinical cases in area Geneva(as noted in other industrialized countries), reporting the specific NTM distribution is important and relevant. In this study, the investigators aimed to: 1/ describe the relative prevalence of NTM species in clinical samples analyzed in the Geneva area, covering ca 500'000 inhabitants over a 5-year period; 2/ determine how many culture positive patients were treated; and 3/ specify the clinical sites involved.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study was performed in the Geneva University Hospitals (HUG), a 2008-bed complex providing care for a population of ca. 500'000 inhabitants. All clinical samples sent for microbiological analysis within HUG are treated by the Bacteriology Laboratory of Geneva University Hospitals. An online database is kept up-to-date and includes all samples processed by the laboratory. The investigators performed a comprehensive analysis of all clinical samples included in this database over a 5-year period (2015-2020). This report focuses only on positive results for nontuberculous mycobacteria (NTM).The following items were recorded: age, gender, BMI whenever available, site of infection (when pulmonary: description of main radiological abnormalities), presence and type of immunosuppression, relevant pulmonary and non-pulmonary comorbidities, results of microscopy, and NTM species identified. The investigators also recorded whether the patient was treated for the identified NTM or not and if a susceptibility profile had been determined (this is not routinely performed and must be requested by the clinician).

    The study protocol was approved by their local ethics committee

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    231 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Nontuberculous Mycobacteria Identified in Clinical Samples in the Geneva Area Over a Period 2015-2020
    Actual Study Start Date :
    Aug 1, 2020
    Actual Primary Completion Date :
    Nov 1, 2020
    Actual Study Completion Date :
    Dec 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Identify nontuberculous mycobacteria species [2015-2020]

      Results of microscopy (positive or negative smear examination), and NTM species were identified (Rapidly or slow growing mycobacteria)

    Secondary Outcome Measures

    1. Baseline characteristics of patients [2015-2020]

      Age (in years),

    2. Baseline characteristics of patients [2015-2020]

      gender

    3. Baseline characteristics of patients [2015-2020]

      BMI (in kg/m2)

    4. Baseline characteristics of patients [2015-2020]

      site of infection (pulmonary or extrapulmonary)

    5. Baseline characteristics of patients [2015-2020]

      presence and type of immunosuppression( HIV co-infection, chemotherapy, glucocorticoids)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion criteria - patients with positive clinical samples for nontuberculous mycobacteria (NTM)

    Exclusion criteria

    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Geneva University Hospital Geneva Switzerland 1205

    Sponsors and Collaborators

    • University Hospital, Geneva

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jean-Paul Janssens, Professor Jean-Paul Janssens, University Hospital, Geneva
    ClinicalTrials.gov Identifier:
    NCT04718571
    Other Study ID Numbers:
    • 2020-00872
    First Posted:
    Jan 22, 2021
    Last Update Posted:
    Jan 22, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mycobacterium Infections

    Study Results

    No Results Posted as of Jan 22, 2021