Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT03042260
Eligibility Criteria:
Inclusion Criteria:
* Systemic Lupus Erythematosus according to the American College of Rheumatology Criteria
* On a daily dose of prednisone of ≥ 15 mg/d or equivalent, and that are expected to remain on the this dose for at least 1 month.
* Have signed an informed consent
Exclusion Criteria:
* Absolute contraindication to receive TMP-SMX (known allergy to TMP-SMX or sulfa drugs; TMP-SMX induced thrombocytopenia)
* Received TMP-SMX treatment in the previous month
* Creatinine clearance \<30ml/min/m2
* Chronic viral infection (Hepatitis C virus, Hepatitis B virus, Human immunodeficiency virus)
* Malignant neoplasm, except for skin neoplasm
* Primary immune deficiencies
* Solid organ or hematopoietic stem cell transplant recipients
* Pregnancy or Breastfeeding
* Current active infection, except mild active infections that to the judgement of the primary investigator do not jeopardize the study outcomes (e.g. tinea).
* Uncontrolled chronic infection (e.g. tuberculosis- intensive phase treatment), except mild active chronic infections that to the judgement of the primary investigator do not jeopardize the study outcomes (e.g. onychomycosis).
* Controlled chronic infection, that needs to be treated or prevented with TMP-SMX.
* Absolute Neutrophil Count \< 750/mm3, platelets \<30x10\^9/L, o hemoglobin \<7 g/dL
* Patients receiving Methotrexate
* Patients participating in another research study that to the judgement of the principal investigator could jeopardize the safety or efficacy of the study drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03042260
Study Brief:
Protocol Section:
NCT03042260