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NCT Number: NCT04718571

An Ecological Analysis of Nontuberculous Mycobacteria in the Geneva Area (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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Geneva University Hospital

Geneva, 1205, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Identify nontuberculous mycobacteria species

    Time frame: 2015-2020

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

Secondary outcomes

  1. Baseline characteristics of patients

    Time frame: 2015-2020

    Age (in years),

  2. Baseline characteristics of patients

    Time frame: 2015-2020

    gender

  3. Baseline characteristics of patients

    Time frame: 2015-2020

    BMI (in kg/m2)

  4. Baseline characteristics of patients

    Time frame: 2015-2020

    site of infection (pulmonary or extrapulmonary)

  5. Baseline characteristics of patients

    Time frame: 2015-2020

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

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 22, 2021
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.