Clinical trial NCT02280902: Incidence and Risk Factors for Infections in Patient Treated With Corticosteroids, Immunosuppressive Drugs or Biotherapy for Immunologic and Inflammatory Diseases
Official title: Incidence and Risk Factors for Infections in Patient Treated With Corticosteroids, Immunosuppressive Drugs or Biotherapy for Immunologic and Inflammatory Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunologic and Inflammatory Diseases
Keywords: auto-immune diseases
inflammatory diseases
risk factors
infections
cohort study
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Ministry for Health and Solidarity, France
First posted: 2014-11-02
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient treated with corticosteroids, immunosuppressive drugs or biotherapy for immunologic and inflammatory diseases

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Viral, bacterila, fungal or parasitic infection leading to hospitalization
timeFrame: 30 months after the inclusion
Secondary outcomes:
measure: Biological and immunological markers
timeFrame: Each 6 months from baseline for 30 months
measure: Morbidity
timeFrame: Each 6 months from baseline for 30 months
Other outcomes:
Locations:
city: Agen
country: France
facility: Service de Médecine Interne - CH d'Agen
city: Bordeaux
country: France
facility: Service de Médecine Interne et maladies Infectieuses - Hôpital Saint-André
city: Libourne
country: France
facility: service de médecine interne - CH de Libourne
city: Limoges
country: France
facility: Service de Médecine Interne - CHU de Limoges
city: Pau
country: France
facility: Service de Médecine Interne - CH de Pau
city: Toulouse
country: France
facility: service Médecine Interne - CHU de Toulouse - Hôpital Purpan (5)
city: Toulouse
country: France
facility: service Médecine Interne - CHU de Toulouse - Hôpital Purpan (7)
Study officials:
affiliation: University Hospital Bordeaux, France
name: Fabrice BONNET, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bordeaux, France
name: Rodolphe THIEBAUT, Prof.
role: STUDY_CHAIR
References: