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| Name | Class |
|---|---|
| Ministry for Health and Solidarity, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with immunologic and inflammatory diseases | Patient treated with corticosteroids, immunosuppressive drugs or biotherapy for immunologic and inflammatory diseases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Viral, bacterila, fungal or parasitic infection leading to hospitalization | 30 months after the inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Morbidity |
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Inclusion Criteria:
Exclusion Criteria:
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Patient treated with corticosteroids, immunosuppressive drugs or biotherapy for immunologic and inflammatory diseases
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| Name | Affiliation | Role |
|---|---|---|
| Fabrice BONNET, Prof. | University Hospital Bordeaux, France | Principal Investigator |
| Rodolphe THIEBAUT, Prof. | University Hospital Bordeaux, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Médecine Interne - CH d'Agen | Agen | 47923 | France | |||
| Service de Médecine Interne et maladies Infectieuses - Hôpital Saint-André |
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- Blood sampling
|
| Each 6 months from baseline for 30 months |
| Bordeaux |
| 33075 |
| France |
| service de médecine interne - CH de Libourne | Libourne | France |
| Service de Médecine Interne - CHU de Limoges | Limoges | 87042 | France |
| Service de Médecine Interne - CH de Pau | Pau | 64000 | France |
| service Médecine Interne - CHU de Toulouse - Hôpital Purpan (5) | Toulouse | 31300 | France |
| service Médecine Interne - CHU de Toulouse - Hôpital Purpan (7) | Toulouse | France |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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