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

Immunologic and Inflammatory Diseases Clinical Trial

— INFIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280902
• Other study ID #: CHUBX 2013/25
• Status: Completed
• Start date: February 16, 2016
• Est. completion date: November 19, 2021

Study information

• Verified date: February 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Monitoring of neutrophils, lymphocytes, immune activation markers, immunoglobulins have not been prospectively studied in such patients. Preliminary retrospective studies have shown that total lymphopenia was independently associated with an increased risk of infections. A previous retrospective study from our group have also shown that total lymphopenia and CD3- lymphopenia three months after the beginning of rituximab was associated with infections.

The determinants of infections occurring during the course of immune and inflammatory diseases treated with corticoids and immunosuppressive drugs or biotherapy are probably multiples. We hypothesized that the following variables may have an impact on the risk of infections in those patients: Epidemiological: gender, social situation, Clinical: causal disease, comorbidities, vaccination status, Therapeutic: type and doses of corticosteroids and immunosuppressive drugs/biotherapy, prevention treatment Biological : neutrophils, total lymphocytes, CD4-T lymphocytes, CD8-T lymphocytes, B lymphocytes, immune activation (HLA-DR+ lymphocytes), CD5 and CD19 lymphocytes, CD27/IgD lymphocytes, immunoglobulins IgA, IgM, IgG.

On the other side, the impact of infection on the clinical course of immunologic or inflammatory disease have been poorly described and will be documented by this longitudinal study.

After inclusion in the present study, patients will be followed on a 30 months period and monitored at M3, M6, M12, M24 to describe the impact of treatment on clinical and biological variables. Every clinical event will be prospectively reported and validated by a specific committee.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 19, 2021
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Immune or inflammatory disease : Lupus, antiphospholipid syndrome, Sjogren syndrome, inflammatory myositis, immunologic thrombopenic purpura, autoimmune hemolytic anemia, Evan's syndrome, systemic vasculitis, Behcet disease.

• Indication of corticosteroid therapy > 20 mg for at least 3 months and/or immunosuppressive or biologic agent.

• Information consent

Exclusion Criteria:

• Previous treatment with immunosuppressive or biological agents, or cumulative dose of steroids > 1g last 6 months

• Splenectomy

• Pregnancy

• Evoluting Cancer

Related Conditions & MeSH terms

• Immunologic and Inflammatory Diseases
• Infections

Intervention

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.

Locations

Country	Name	City	State
France	Service de Médecine Interne - CH d'Agen	Agen
France	Service de Médecine Interne et maladies Infectieuses - Hôpital Saint-André	Bordeaux
France	service de médecine interne - CH de Libourne	Libourne
France	Service de Médecine Interne - CHU de Limoges	Limoges
France	Service de Médecine Interne - CH de Pau	Pau
France	service Médecine Interne - CHU de Toulouse - Hôpital Purpan (5)	Toulouse
France	service Médecine Interne - CHU de Toulouse - Hôpital Purpan (7)	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Ministry for Health and Solidarity, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral, bacterila, fungal or parasitic infection leading to hospitalization		30 months after the inclusion
Secondary	Biological and immunological markers	The following items will be assessed every 6 months : total White blood cell CD3 CD4 CD8 HLA-DR+ B cells CD19+ B cells CD5+/- CD27/IgD NK cells IgA, IgM, IgG levels	Each 6 months from baseline for 30 months
Secondary	Morbidity		Each 6 months from baseline for 30 months