Clinical Research for the Diagnosis of Tick-borne Diseases in Patients With Unexplained Acute Fever
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evidence of immunoglobulin M and immunoglobulin G titres in acute and convalescent serum or a fragment of the specific gene from patients' whole blood
研究概览
简要总结
The study will use several laboratory diagnoses in the diagnosis of patients with fever，to find out which will be more helpful for making an accurate diagnosis in the early period of Tickborne Diseases.
详细描述
Tickborne Diseases(TBDs) spread throughout many countries and regions. In recent years, the incidence has a tendency to rise continuously. The clinical symptoms and laboratory features of tick-borne diseases are always of no specific, and the diagnostic methods available, such as observing the pathogen after cultivation or by the method of Gimenez、serological tests for antibody always can't make a timely diagnosis, especially in the early period of the disease. The development of polymerase chain reaction(PCR) has been applied for pathogen detection, and showed high sensitivity and specificity,and may contribute to early diagnose，but no standardized method of PCR has been as yet proposed. This study mean to explore several laboratory diagnoses to find out which will be more helpful for making an accurate diagnosis in the early period of TBDs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients have fever more than one week
- •temperature is higher than 38℃ Celsius degree
- •full of physical examination and laboratory examination have been carried out after one week，but still cannot make a definite diagnosis
排除标准
- •fever for non-infectious diseases such as rheumatic autoimmune disease or with tumor
- •we find that the patient selected does not meet the selection criteria within the observation period
- •patients leave with automatic discharge
结局指标
主要结局
Evidence of immunoglobulin M and immunoglobulin G titres in acute and convalescent serum or a fragment of the specific gene from patients' whole blood
时间窗: within the first 14 days in hospital
次要结局
- the sensitivity and specificity of the laboratory diagnostic methods Related to the reserach(up to three years)
研究者
Fu Xueying
Clinical Research for the Diagnosis of Tick-borne Diseases in Patients With Unexplained Acute Fever
Beijing Friendship Hospital