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

• Status: Unknown status
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Collaborator: National Council of Science and Technology, Mexico
• Treatments: Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

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.