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

Nontuberculous Mycobacteria Identified in Clinical Samples in the Geneva Area Over a Period 2015-2020

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.

Study Overview

• Status: Completed
• Conditions: Ecology of Nontubercuous Mycobacteria; Geneva Area

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 Type: Observational
• Enrollment (Actual): 231

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Geneva University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with positive clinical samples for nontuberculous mycobacteria (NTM)

Description

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

Exclusion criteria

- None

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline characteristics of patients	Age (in years),	2015-2020
Baseline characteristics of patients	gender	2015-2020
Baseline characteristics of patients	BMI (in kg/m2)	2015-2020
Baseline characteristics of patients	site of infection (pulmonary or extrapulmonary)	2015-2020
Baseline characteristics of patients	presence and type of immunosuppression( HIV co-infection, chemotherapy, glucocorticoids)	2015-2020

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: January 17, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 17, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections
• Other Study ID Numbers: 2020-00872

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No