NCT02280902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 3, 2014

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 16, 2016

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2021

Completed
Last Updated

February 3, 2022

Status Verified

February 1, 2022

Enrollment Period

5.8 years

First QC Date

September 19, 2014

Last Update Submit

February 2, 2022

Conditions

Immunologic and Inflammatory Diseases

Keywords

auto-immune diseasesinflammatory diseasesrisk factorsinfectionscohort study

Outcome Measures

Primary Outcomes (1)

  • Viral, bacterila, fungal or parasitic infection leading to hospitalization

    30 months after the inclusion

Secondary Outcomes (2)

  • Biological and immunological markers

    Each 6 months from baseline for 30 months

  • Morbidity

    Each 6 months from baseline for 30 months

Study Arms (1)

Patient with immunologic and inflammatory diseases

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

Biological: Blood samples

Interventions

Blood samplesBIOLOGICAL

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.

Patient with immunologic and inflammatory diseases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Previous treatment with immunosuppressive or biological agents, or cumulative dose of steroids \> 1g last 6 months
  • Splenectomy
  • Pregnancy
  • Evoluting Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Service de Médecine Interne - CH d'Agen

Agen, 47923, France

Location

Service de Médecine Interne et maladies Infectieuses - Hôpital Saint-André

Bordeaux, 33075, France

Location

service de médecine interne - CH de Libourne

Libourne, France

Location

Service de Médecine Interne - CHU de Limoges

Limoges, 87042, France

Location

Service de Médecine Interne - CH de Pau

Pau, 64000, France

Location

service Médecine Interne - CHU de Toulouse - Hôpital Purpan (5)

Toulouse, 31300, France

Location

service Médecine Interne - CHU de Toulouse - Hôpital Purpan (7)

Toulouse, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

\- Blood sampling

MeSH Terms

Conditions

Infections

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Fabrice BONNET, Prof.

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

  • Rodolphe THIEBAUT, Prof.

    University Hospital Bordeaux, France

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2014

First Posted

November 3, 2014

Study Start

February 16, 2016

Primary Completion

November 19, 2021

Study Completion

November 19, 2021

Last Updated

February 3, 2022

Record last verified: 2022-02

Locations

FR(7)