Efficacy and Safety of Prophylactic Treatment for Pneumocystis Jirovecii Pneumonia (PJP) in Patients With Autoimmune Inflammatory Rheumatic Disease (AIIRD)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Number of participants with PJP infection
研究概览
简要总结
This is an open-labeled, prospective clinical study aims at collecting and analyzing baseline characteristics of autoimmune inflammatory rheumatic disease (AIIRD) patients receiving sulfanilamide for preventive purposes, as well as subsequent follow-up data, in order to assess the efficacy and safety of the medication. Additionally, through a stratified analysis of risk factors, the investigators aim to identify the AIIRD population that would benefit most from preventive medication based on a favorable benefit-risk ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •The patient was diagnosed with AIIRD according to the International Classification of Diseases and had received steroids or immunosuppressive therapy;
- •The patient had not received standard PJP treatment before enrollment, including the first-line treatment drug TMP/SMZ, or other second-line treatment drugs (including Pentamidine, Atorvastatin, Caspofungin, etc.);
- •The patient was at least 18 years old at the time of enrollment;
排除标准
- •Serious health problems or diseases, including (but not limited to) the following: severe liver damage (ALT, AST elevated above normal value by more than 5 times), severe renal insufficiency (GFR < 30mL/min or Scr > 445umol/L), severe myelosuppression (Hb < 65g/L, PLT < 25×10^9/L or neutrophils < 0.5×10^9/L);
- •Screening test indicates infection with human immunodeficiency virus (HIV), history of lymphomatous hyperplasia of the lymphatic tissue or any malignant tumor of any organ system within the past 5 years, or history of organ transplantation;
- •Participants with a history of allergy to sulfonamide drugs, megaloblastic anemia due to folate deficiency;
- •Pregnant and lactating women;
- •Any medical or psychological condition that the investigator believes would interfere with the participant's ability to comply with the protocol or complete the study;
- •Patients who refuse to comply with the requirements of this study and complete the study;
- •Any other situation that the investigator considers unsuitable for participation in the study (for reasons including but not limited to management reasons).
研究组 & 干预措施
TMP/SMX (with PJP high risk)
AIIRD patients who have PJP high risk and receive prophylactic Trimethoprim/ Sulfamethoxazole (TMP/SMZ) treatment; Drug intervention: Patients receive Trimethoprim/Sulfamethoxazole (TMP/SMX) 480 mg p.o. every day as PJP Prophylaxis.
干预措施: Trimethoprim/Sulfamethoxazole (Drug)
TMP/SMX (with PJP low-risk)
AIIRD patients who have PJP low risk and receive prophylactic Trimethoprim/ Sulfamethoxazole (TMP/SMZ) treatment; Drug intervention: Patients receive Trimethoprim/Sulfamethoxazole (TMP/SMX) 480 mg p.o. every day as PJP Prophylaxis.
干预措施: Trimethoprim/Sulfamethoxazole (Drug)
结局指标
主要结局
Number of participants with PJP infection
时间窗: 6 months, 12 months
Defined as documentation/diagnosis of Pneumocystis from a properly obtained specimen (induced sputum, bronchoalveolar lavage, or biopsy) in a patient with clinical manifestations compatible with PJP.
次要结局
- TMP/SMZ related adverse drug reactions(6 months, 12 months)
- PJP-related mortality(6 months, 12 months)
- All cause mortality(6 months, 12 months)