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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status and phase: Unknown; Phase 4

Conditions: Lupus Erythematosus, Systemic

Treatments: Drug: Placebo Oral Tablet; Drug: Trimethoprim-Sulfamethoxazole

Study type: Interventional

Funder types: Other

Identifiers

NCT03042260

INF-2056-17/20-1

Details and patient eligibility

About

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.

Enrollment: 310 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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310 participants in 2 patient groups, including a placebo group

Trimethoprim-Sulfamethoxazole (TMP-SMX)

Experimental group

Description:

Trimethoprim-Sulfamethoxazole 180mg/800mg oral tablet, 3 times a week, for 6 months. Subjects may remain on the drug longer (maximum 1 year), if they continue to receive intermediate or high dose steroids at the end of 6 months.

Treatment:

Drug: Trimethoprim-Sulfamethoxazole

Placebo

Placebo Comparator group

Description:

Tablets that look exactly the same as the experimental drug, 3 times a week, for 6 months. Subjects may remain on the placebo longer (maximum 1 year), if they continue to receive intermediate or high dose steroids at the end of 6 months.

Treatment:

Drug: Placebo Oral Tablet