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Incidence and Risk Factors for Infections in Patient Treated With Corticosteroids, Immunosuppressive Drugs or Biotherapy for Immunologic and Inflammatory Diseases

NCT02280902 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2022-02-03

No results posted yet for this study

Summary

Infections represent the first cause of death and of morbidity in people treated for immunologic and inflammatory diseases with corticosteroids, immunosuppressive drugs or biotherapy. Epidemiological, clinical, biological and therapeutic determinants of these infections are poorly understood. There is no recommendation for the prevention and treatment of infections in this particular field.

Purpose : Recent therapeutic trials evaluating immunosuppressive and biotherapy (cyclophosphamide, mycophenolate mofetil, rituximab, belimumab) in the field of immunologic and inflammatory diseases have found a risk of severe infection of 7 to 18% during the first year after the beginning of the treatment. Thus, the main objective of the study is to describe the incidence and risk-factors for infections in people treated with such agents for immunologic and inflammatory diseases.

Conditions

  • Immunologic and Inflammatory Diseases

Interventions

BIOLOGICAL

Blood samples

Systematic follow-up (M3, M6, M12, M18, M24, M30) will be implemented to complete epidemiologic, clinical, therapeutic and biological data during a 30 months period. Specific measure of immune cells, markers of immune activation, immunoglobulins as described above will be performed at M3, M6, M12 and M24. A biologic collection (serum and cells) will be performed at the same time points for future prognostic studies.

Sponsors & Collaborators

  • Ministry for Health and Solidarity, France

    collaborator OTHER_GOV

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Fabrice BONNET, Prof. · University Hospital Bordeaux, France

  • Rodolphe THIEBAUT, Prof. · University Hospital Bordeaux, France

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-16
Primary Completion
2021-11-19
Completion
2021-11-19

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02280902 on ClinicalTrials.gov