Infection
Conditions
Brief summary
IL-2 is a pleiotropic cytokine which can regulate or stimulate the differentiation and function of CD4+, CD8+ and NK cells. An opened-labelled trial and a retrospective study have indicated the incidence of infection is lower in the treatment of low-dose IL-2 combined with corticosteroid and immunosuppressor. We are going to conduct a multi-center prospective observational study to verify the above results.
Detailed description
We are going to conduct a multi-center prospective observational study, and plan to enroll 500 SLE patients. Low-dose IL-2 is defined as 100IU IL-2 injected subcutaneously every other day for two weeks, followed by two-week break as one treatment cycle, and at least three weeks.There will be 250 patients in low-dose IL-2 group which treat with IL-2 combined with steroid and immunosuppressor. Non-IL-2 group is only treat with steroid and immunosuppressor. These patients are followed by every one month until get infected, otherwise, patients will be followed for two years. We focus on the type, positive microorganisms, grade and treatment of infection. Then, we will compare the differences of above parameters between these two groups.
Interventions
DRUGIL-2
IL-2 is a medicine which can use in autoimmune disease, infection or cancer with different dose. Low-dose IL-2 preferentially used in autoimmune disease, such as SLE. Our enrolled SLE patients will divided into two groups depend on whether use IL-2 or not, combined with corticosteroid and immunosuppressor.
Sponsors
Peking University People's Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* SLE patients diagnosed by the ACR Criteria of 1987; * Treated with low-dose IL-2, corticosteroid and immunosuppressor for SLE. * Consent to participate in this study. * Regular follow-up for at least 2 years.
Exclusion criteria
* Other autoimmune disease; * Without treatment of low-dose IL-2, corticosteroid and immunosuppressor for SLE. * Mental disorder without regular or specific treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of infection of two groups | 2 years | Infection is confirmed by art least one infectious specialist or rheumatologist, by means of clinical symptoms, positive microorganisms culture, response to antibiotic therapy. |
Countries
China
Contacts
Primary ContactJiali Chen, MD
Outcome results
None listed