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

NCT05030701 | Unknown

• 1 other identifier: PI2021_843_0072
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Mycobacterium; Cancer; Treatment Side Effects

Keywords

Mycobacterium; cancer; Treatment Side Effects

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

cancerous patients

non cancerous patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients infected with Nontuberculous mycobacteria, collected from CHU Amiens 2015 to 2020, extracted from the medical information service by the RUM (medical unit summary) with a diagnostic code ICD-10 which is the International Classification of diseases, commonly known as the international statistical classification of diseases and related health problems and Chapters A31.0, A31.8, A31.9.

You may qualify if:

• 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.

You may not qualify if:

• age less than 18 years
• Patients diagnosed by NTM without treatment.
• Patients with a positive sample of NTM but without infection.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Mycobacterium Infections; Neoplasms

Condition Hierarchy (Ancestors)

Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Jean Philippe LANOIX, MD

CONTACT

03 22 66 83 73; Lanoix.jean-philippe@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: September 1, 2021
• Study Start: July 13, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)