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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05030701
Other study ID # PI2021_843_0072
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 13, 2021
Est. completion date October 2023

Study information

Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Jean Philippe LANOIX, MD
Phone 03 22 66 83 73
Email Lanoix.jean-philippe@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Non-tuberculous mycobacteria (NTM) are increasingly common and have a poor prognosis: 5-year mortality can reach 40 to 50%, depending on the type of mycobacteria and the immune system of the host involved. Cancer patients are at higher risk of infectious morbidity and mortality, which may be due to disease-related immune dysfunction, immunosuppressive effects of chemotherapy, or long-term placement of a vascular catheter. However, data on the treatment of NTM species that cause infections and the disease characteristics of these pathogens in cancer patients are limited despite the growing cancer population worldwide. Recently, M. avium infections have been described in patients suffering from cancers (hematological or not), in particular in patients receiving checkpoint inhibitors. Although the proportion of M. avium pneumonia in retrospective series is low (0.8-2%), it has been shown that this population is younger, suffers less from sub-pulmonary pathology. (indicating immunosuppression in these patients) but are therefore treated less than non-cancerous subjects. This retrospective study in CHU Amiens is searching on the number of side effects of NTM treatment in two groups (cancerous and no cancerous) to assess the cause of the decrease of NTM treatment in cancerous patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 43
Est. completion date October 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age equal or more than 18 years18 - Patients diagnosed by an infection with non-tuberculous mycobacteria according to ATS guidelines. - Patients received the NTM treatment. Exclusion Criteria: - age less than 18 years - Patients diagnosed by NTM without treatment. - Patients with a positive sample of NTM but without infection. - Exclusion of other disorders such as tuberculous.

Study Design


Locations

Country Name City State
France CHU Amiens Picardie Amiens Picardie

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary variation of side effects number of non-tuberculous mycobacteria treatment between cancerous and non cancerous patient groups. The main objective of this study is to determine the number of side effects of the treatment of non-tuberculous mycobacteria in patients with this infection with or without cancer at the CHU Picardie Amiens. 3 months
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