Clinical trial NCT04718571: An Ecological Analysis of Nontuberculous Mycobacteria in the Geneva Area (2015-2020)
Official title: Nontuberculous Mycobacteria Identified in Clinical Samples in the Geneva Area Over a Period 2015-2020
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ecology of Nontubercuous Mycobacteria
Geneva Area
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 231
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with positive clinical samples for nontuberculous mycobacteria (NTM)

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.

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

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

Exclusion criteria

- None

Primary outcomes:
measure: Identify nontuberculous mycobacteria species
timeFrame: 2015-2020
Secondary outcomes:
measure: Baseline characteristics of patients
timeFrame: 2015-2020
measure: Baseline characteristics of patients
timeFrame: 2015-2020
measure: Baseline characteristics of patients
timeFrame: 2015-2020
measure: Baseline characteristics of patients
timeFrame: 2015-2020
measure: Baseline characteristics of patients
timeFrame: 2015-2020
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
References: