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

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ClinicalTrials.gov Identifier: NCT02280902
Recruitment Status : Recruiting
First Posted : November 2, 2014
Last Update Posted : March 23, 2020
Sponsor:
Collaborator:
Ministry for Health and Solidarity, France
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date September 19, 2014
First Posted Date November 2, 2014
Last Update Posted Date March 23, 2020
Actual Study Start Date February 16, 2016
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 29, 2014)
Viral, bacterila, fungal or parasitic infection leading to hospitalization [ Time Frame: 30 months after the inclusion ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 29, 2014)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
- Blood sampling
Sampling Method Non-Probability Sample
Study Population Patient treated with corticosteroids, immunosuppressive drugs or biotherapy for immunologic and inflammatory diseases
Condition Immunologic and Inflammatory Diseases
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.
Study Groups/Cohorts Patient with immunologic and inflammatory diseases
Patient treated with corticosteroids, immunosuppressive drugs or biotherapy for immunologic and inflammatory diseases
Intervention: Biological: Blood samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 29, 2014)
217
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Fabrice BONNET, Prof. (0) 556795826 ext +33 fabrice.bonnet@chu-bordeaux.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02280902
Other Study ID Numbers CHUBX 2013/25
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor University Hospital, Bordeaux
Collaborators Ministry for Health and Solidarity, France
Investigators
Principal Investigator: Fabrice BONNET, Prof. University Hospital Bordeaux, France
Study Chair: Rodolphe THIEBAUT, Prof. University Hospital Bordeaux, France
PRS Account University Hospital, Bordeaux
Verification Date March 2020