Immunologic and Inflammatory DiseasesINFIMNCT02280902
Incidence and Risk Factors for Infections in Patient Treated With Corticosteroids, Immunosuppressive Drugs or Biotherapy for Immunologic and Inflammatory Diseases
An observational study of Immunologic and Inflammatory Diseases, run by University Hospital, Bordeaux at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunologic and Inflammatory Diseases
- What is being tested?
- Blood samples
- How many people
- 72 participants
- Where
- 7 sitesFrance
- Study dates
- 16 Feb 2016to 19 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient treated with corticosteroids, immunosuppressive drugs or biotherapy for immunologic and inflammatory diseases
Who may be able to join
- 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
Who cannot join
- Previous treatment with immunosuppressive or biological agents, or cumulative dose of steroids > 1g last 6 months
- Splenectomy
- Pregnancy
- Evoluting Cancer
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Service de Médecine Interne - CH d'Agen
Agen, 47923
Service de Médecine Interne et maladies Infectieuses - Hôpital Saint-André
Bordeaux, 33075
service de médecine interne - CH de Libourne
Libourne
Service de Médecine Interne - CHU de Limoges
Limoges, 87042
Service de Médecine Interne - CH de Pau
Pau, 64000
service Médecine Interne - CHU de Toulouse - Hôpital Purpan (5)
Toulouse, 31300
service Médecine Interne - CHU de Toulouse - Hôpital Purpan (7)
Toulouse
About this study
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.
Read the 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.
- Conditions
- Immunologic and Inflammatory Diseases
- Being tested
- Blood samples
- Keywords
- auto-immune diseases, inflammatory diseases, risk factors, infections, cohort study
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient with immunologic and inflammatory diseases | Patient treated with corticosteroids, immunosuppressive drugs or biotherapy for immunologic and inflammatory diseases Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral, bacterila, fungal or parasitic infection leading to hospitalization
Measured: 30 months after the inclusion
Secondary outcomes (2)
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
Measured: Each 6 months from baseline for 30 months
Morbidity
Measured: Each 6 months from baseline for 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study start16 Feb 2016
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunologic and Inflammatory DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry for Health and Solidarity, France
- Responsible party
- Sponsor
- Investigators
- Fabrice BONNET, Prof., Principal investigator, University Hospital Bordeaux, FranceRodolphe THIEBAUT, Prof., Study chair, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280902
- Sponsor's protocol ID
- CHUBX 2013/25
- Acronym
- INFIM
- Status last verified
- Feb 2022
- First submitted
- 19 Sep 2014
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors for Infections in Patient Treated With Corticosteroids, Immunosuppressive Drugs or Biotherapy for Immunologic and Inflammatory Diseases
- ClinicalTrials.gov ID
- NCT02280902
- Acronym / sponsor ID
- INFIM / CHUBX 2013/25
- Conditions
- Immunologic and Inflammatory Diseases
- Keywords
- auto-immune diseases, inflammatory diseases, risk factors, infections, cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry for Health and Solidarity, France
- Study start
- 16 Feb 2016 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 3 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with immunologic and inflammatory diseases | – | Biological: Blood samplesPatient treated with corticosteroids, immunosuppressive drugs or biotherapy for immunologic and inflammatory diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient treated with corticosteroids, immunosuppressive drugs or biotherapy for immunologic and inflammatory diseases
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Previous treatment with immunosuppressive or biological agents, or cumulative dose of steroids > 1g last 6 months
- Splenectomy
- Pregnancy
- Evoluting Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesSystematic 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. | Biological | Patient with immunologic and inflammatory diseases |
Primary outcome
Viral, bacterila, fungal or parasitic infection leading to hospitalization
Time frame: 30 months after the inclusion
2 secondary outcomes
Biological and immunological markers
Time frame: Each 6 months from baseline for 30 months
Morbidity
Time frame: Each 6 months from baseline for 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
Related trials for Immunologic and Inflammatory Diseases
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruitingPhase 2/3
Phase 2 and 3 Placebo Controlled & Long-term Extension Study of Rilzabrutinib in Adults With iCVID to Evaluate Efficacy, Safety, and Tolerability
Immunodeficiency Common Variable
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
Enrolling by invitationObservational study
Evaluation and Long-Term Follow-up of Patients With Inflammatory Disorders
Inflammation
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice BONNET, Prof. principal investigator
University Hospital Bordeaux, France
Rodolphe THIEBAUT, Prof. study chair
University Hospital Bordeaux, France
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunologic and Inflammatory Diseases, run by University Hospital, Bordeaux at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral, bacterila, fungal or parasitic infection leading to hospitalization (time frame: 30 months after the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.