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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04718571
Other study ID # 2020-00872
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date December 1, 2020

Study information

Verified date January 2021
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 231
Est. completion date December 1, 2020
Est. primary completion date November 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion criteria - patients with positive clinical samples for nontuberculous mycobacteria (NTM) Exclusion criteria - None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Geneva University Hospital Geneva

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identify nontuberculous mycobacteria species Results of microscopy (positive or negative smear examination), and NTM species were identified (Rapidly or slow growing mycobacteria) 2015-2020
Secondary Baseline characteristics of patients Age (in years), 2015-2020
Secondary Baseline characteristics of patients gender 2015-2020
Secondary Baseline characteristics of patients BMI (in kg/m2) 2015-2020
Secondary Baseline characteristics of patients site of infection (pulmonary or extrapulmonary) 2015-2020
Secondary Baseline characteristics of patients presence and type of immunosuppression( HIV co-infection, chemotherapy, glucocorticoids) 2015-2020