The Safety and Effectiveness of Trimethoprim/Sulfamethoxazole as Pneumocystis Carinii Pneumonia (PCP) Prophylaxis in Patients With Connective Tissue Diseases
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Documented PCP infection
研究概览
简要总结
Evaluation the efficacy and safety profile of trimethoprim/sulfamethoxazole as Pneumocystis carinii pneumonia (PCP) prophylaxis in Patients With Connective Tissue Diseases (CTD) treated with high-dose glucocorticoids and immunosuppressive agents.
Open-labeled, randomized, prospective single-center clinical trial. Observation period of 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years with informed consent
- •SLE, Sjögren syndrome, Polymyositis or Dermatomyositis, defined by consensus classification criteria
- •concomitant high dose glucocorticoid, defined as >1mg/kg/d prednisone or equivalent
- •concomitant cyclophosphamide, cyclosporine or mycophenolate mofetil
排除标准
- •Pregnant or lactating
- •WBC< 4×10^9/L，PLT<100×10^9/L
- •Serum ALT or AST > 2 times upper limit of normal
- •Serum creatinine > 1.5 mg/dL
- •Severe hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine or cerebral disease
- •Active infection, including HIV, HCV, HBV, tuberculosis or PCP
- •concomitant antibiotics other than trimethoprim/sulfamethoxazole
- •Patient with malignancy
- •Drug allergy, especially trimethoprim/sulfamethoxazole
研究组 & 干预措施
TMP/SMX
Patients received Trimethoprim/Sulfamethoxazole (TMP/SMX) 80 mg/400 mg p.o. every day as PCP Prophylaxis.
干预措施: Trimethoprim/Sulfamethoxazole (Drug)
结局指标
主要结局
Documented PCP infection
时间窗: 12 weeks.
Documented Pneumocystis carinii pneumonia infection: defined as documentation of Pneumocystis from a properly obtained specimen (induced sputum, bronchoalveolar lavage, or biopsy) in a patient with clinical manifestations compatible with PCP.
次要结局
- All cause mortality(12 weeks)
- PCP-related hospitalization(12 weeks)
- PCP-related mortality(12 weeks)
- Other infections(12 weeks)
研究者
Fengchun Zhang
Professor
Peking Union Medical College Hospital