MYCATRES: Toxicity of Treatments for Non-tuberculous Mycobacterial Infections in Cancer Patients or Not

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT05030701
Collaborator
(none)
43
1
2.6
16.4

Study Details

Study Description

Brief 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

  1. 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    43 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Toxicity of Treatments for Non-tuberculous Mycobacterial Infections in Cancer Patients or Not
    Actual Study Start Date :
    Jul 13, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2021
    Anticipated Study Completion Date :
    Oct 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    cancerous patients

    non cancerous patients

    Outcome Measures

    Primary Outcome Measures

    1. variation of side effects number of non-tuberculous mycobacteria treatment between cancerous and non cancerous patient groups. [3 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Amiens Picardie Amiens Picardie France 80054

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire, Amiens

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire, Amiens
    ClinicalTrials.gov Identifier:
    NCT05030701
    Other Study ID Numbers:
    • PI2021_843_0072
    First Posted:
    Sep 1, 2021
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire, Amiens
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 1, 2021