Prophylactic Trimethoprim-Sulfamethoxazole for the Prevention of Serious Infections in Patients With Systemic Lupus Erythematosus: a Randomized Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Frequency of non-viral severe infections
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Trimethoprim-Sulfamethoxazole (TMP-SMX)
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.
干预措施: Trimethoprim-Sulfamethoxazole (Drug)
Placebo
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.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Frequency of non-viral severe infections
时间窗: Time on the intervention (maximum 1 year)
Infections that lead to hospitalization for \>24 hours or lead to death.
次要结局
- Serious Adverse Events(Time on the intervention (maximum 1 year))
- Frequency of non-viral infections(Time on the intervention (maximum 1 year))
- Proportion of patients that develop infections resistant to TMP-SMX(Time on the intervention (maximum 1 year))
- Drug discontinuation(1 year)
- Time to first episode of non-viral severe infection(From 2 weeks after randomization until the date of the first episode of a non-viral severe infection, up to 1 year after randomization.)
- All cause mortality or hospitalization(Time on the intervention (maximum 1 year))
研究者
Jennifer M. Cuellar-Rodríguez
Medical Sciences Investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran