Incidence and Risk Factors for Infections in Patient Treated With Corticosteroids, Immunosuppressive Drugs or Biotherapy for Immunologic and Inflammatory Diseases (INFIM)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02280902 |
|
Recruitment Status :
Completed
First Posted : November 2, 2014
Last Update Posted : February 3, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Immunologic and Inflammatory Diseases | Biological: Blood samples |
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.
| Study Type : | Observational |
| Actual Enrollment : | 72 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Incidence and Risk Factors for Infections in Patient Treated With Corticosteroids, Immunosuppressive Drugs or Biotherapy for Immunologic and Inflammatory Diseases |
| Actual Study Start Date : | February 16, 2016 |
| Actual Primary Completion Date : | November 19, 2021 |
| Actual Study Completion Date : | November 19, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Patient with immunologic and inflammatory diseases
Patient treated with corticosteroids, immunosuppressive drugs or biotherapy for immunologic and inflammatory diseases
|
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. |
- Viral, bacterila, fungal or parasitic infection leading to hospitalization [ Time Frame: 30 months after the inclusion ]
- Biological and immunological markers [ Time Frame: Each 6 months from baseline for 30 months ]
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
- Morbidity [ Time Frame: Each 6 months from baseline for 30 months ]
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280902
| France | |
| Service de Médecine Interne - CH d'Agen | |
| Agen, France, 47923 | |
| Service de Médecine Interne et maladies Infectieuses - Hôpital Saint-André | |
| Bordeaux, France, 33075 | |
| service de médecine interne - CH de Libourne | |
| Libourne, France | |
| Service de Médecine Interne - CHU de Limoges | |
| Limoges, France, 87042 | |
| Service de Médecine Interne - CH de Pau | |
| Pau, France, 64000 | |
| service Médecine Interne - CHU de Toulouse - Hôpital Purpan (5) | |
| Toulouse, France, 31300 | |
| service Médecine Interne - CHU de Toulouse - Hôpital Purpan (7) | |
| Toulouse, France | |
| Principal Investigator: | Fabrice BONNET, Prof. | University Hospital Bordeaux, France | |
| Study Chair: | Rodolphe THIEBAUT, Prof. | University Hospital Bordeaux, France |
| Responsible Party: | University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT02280902 |
| Other Study ID Numbers: |
CHUBX 2013/25 |
| First Posted: | November 2, 2014 Key Record Dates |
| Last Update Posted: | February 3, 2022 |
| Last Verified: | February 2022 |
|
auto-immune diseases inflammatory diseases risk factors infections cohort study |
|
Infections |