Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus Erythematous

Prophylactic Trimethoprim-Sulfamethoxazole for the Prevention of Serious Infections in Patients With Systemic Lupus Erythematosus: a Randomized Placebo Controlled Trial

The purpose of this study is to determine whether trimethoprim/sulfamethoxazole is effective in preventing serious infectious complications (those that require hospitalization or lead to death) in patients with lupus erythematosus that receive intermediate or high dose steroids.

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.