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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

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.


Condition or disease Intervention/treatment
Immunologic and Inflammatory Diseases Biological: Blood samples

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.

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Study Type : Observational
Estimated Enrollment : 217 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
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

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.




Primary Outcome Measures :
  1. Viral, bacterila, fungal or parasitic infection leading to hospitalization [ Time Frame: 30 months after the inclusion ]

Secondary Outcome Measures :
  1. 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


  2. Morbidity [ Time Frame: Each 6 months from baseline for 30 months ]

Biospecimen Retention:   Samples With DNA
- Blood sampling


Information from the National Library of Medicine

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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
Study Population
Patient treated with corticosteroids, immunosuppressive drugs or biotherapy for immunologic and inflammatory diseases
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

Information from the National Library of Medicine

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


Contacts
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Contact: Fabrice BONNET, Prof. (0) 556795826 ext +33 fabrice.bonnet@chu-bordeaux.fr

Locations
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France
Service de Médecine Interne - CH d'Agen Not yet recruiting
Agen, France, 47923
Contact: Patrick RISPAL, MD       patrick.rispal@ch-agen.fr   
Principal Investigator: Patrick RISPAL, MD         
Service de Médecine Interne et maladies Infectieuses - Hôpital Saint-André Recruiting
Bordeaux, France, 33075
Contact: Fabrice BONNET, Prof.    (0)5 56 79 58 26 ext +33    fabrice.bonnet@chu-bordeaux.fr   
Principal Investigator: Fabrice BONNET, Prof.         
Sub-Investigator: Partick MERCIE, Prof.         
Sub-Investigator: Julien SENESCHAL, MD         
Sub-Investigator: Jean-François VIALLARD, Prof.         
Sub-Investigator: Pierre MERVILLE, Prof.         
Sub-Investigator: Christophe RICHEZ, MD         
service de médecine interne - CH de Libourne Not yet recruiting
Libourne, France
Contact: Olivier CAUBET, MD       olivier.caubet@ch-libourne.fr   
Service de Médecine Interne - CHU de Limoges Not yet recruiting
Limoges, France, 87042
Contact: Guillaume GONDRAN, MD       guillaume.gondran@chu-limoges.fr   
Principal Investigator: Guillaune GONDRAN, MD         
Service de Médecine Interne - CH de Pau Not yet recruiting
Pau, France, 64000
Contact: Xavier DELBREL, MD       xavier.delbrel@ch-pau.fr   
Principal Investigator: Xavier DELBREL, MD         
service Médecine Interne - CHU de Toulouse - Hôpital Purpan (5) Recruiting
Toulouse, France, 31300
Contact: Laurent SAILLER, Prof.       sailler.l@chu-toulouse.fr   
Principal Investigator: Laurent SAILLER, Prof.         
service Médecine Interne - CHU de Toulouse - Hôpital Purpan (7) Not yet recruiting
Toulouse, France
Contact: Laurent ALRIC, Prof       alric.l@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry for Health and Solidarity, France
Investigators
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Principal Investigator: Fabrice BONNET, Prof. University Hospital Bordeaux, France
Study Chair: Rodolphe THIEBAUT, Prof. University Hospital Bordeaux, France
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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: March 23, 2020
Last Verified: March 2020
Keywords provided by University Hospital, Bordeaux:
auto-immune diseases
inflammatory diseases
risk factors
infections
cohort study
Additional relevant MeSH terms:
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Infection