For Tuberculosis (TB) Clinical Auxiliary Diagnosis of Recombinant Mycobacterium Tuberculosis Allergen ESAT6 - CFP10 Dose of Certain Phase III Clinical Research
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,090
- 试验地点
- 2
- 主要终点
- Immune response of right arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in TB patients
研究概览
简要总结
720 cases TB (Tuberculosis patients) participants、360 cases non-TB participants with lung disease and suspected TB patients who all meet the standard are divided into different groups through a randomized and blind method. Every subject inject intradermally ESAT6-CFP10 and TB-PPD (tuberculin purified protein derivative) in different arms of the same person by blind method. Specific gama-interferon (γ-IFN) detection is needed before the injection.Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At the same time, we observe all kind of adverse events.
详细描述
Firstly, 720 cases TB (Tuberculosis) participants who meet the standard respectively are divided into different groups through a randomized and blind method.
- ESAT6-CFP10(10ug/ml) in left arm
- ESAT6-CFP10(10ug/ml) in right arm. Inject intradermally ESAT6-CFP10 and TB-PPD in different arms of the same participant. For each of participant, the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At the same time, we observe the vital signs (breathing, heart rate, blood pressure and temperature), local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events.
Secondly, 360 cases non-TB participants with lung disease and suspected TB participants are divided into two different groups and the procedure are as the same as 720 cases TB.
Thirdly,suspected TB participants are put under TB (Tuberculosis patients) or non-TB participants with lung disease by diagnosis when out group.
Finally, we calculate the sensitivity (positive coincidence rate) by TB (Tuberculosis patients), the specificity (negative coincidence rate) by non-TB participants with lung disease, and verify the safety and effectiveness of ESAT6-CFP10(10ug/ml) for the clinical auxiliary diagnosis of tuberculosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TB subjects
720 cases TB (Tuberculosis) subjects who meet the standard respectively are divided average into two groups through a randomized and blind method.
360 TB subjects are injected ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm. 360 TB subjects are injected ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.
干预措施: ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm (Biological)
TB subjects
720 cases TB (Tuberculosis) subjects who meet the standard respectively are divided average into two groups through a randomized and blind method.
360 TB subjects are injected ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm. 360 TB subjects are injected ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.
干预措施: ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm (Biological)
non-TB subjects with lung disease and suspected TB subjects
360 cases non-TB subjects with lung disease and suspected TB subjects,who meet the standard respectively are divided average into different groups through a randomized and blind method. 180 non-TB subjects with lung disease are injected ESAT6-CFP10(10ug/ml) in left arm and TB-PPD in right arm. 180 non-TB subjects with lung disease are injected ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm. The study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.
干预措施: ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm (Biological)
non-TB subjects with lung disease and suspected TB subjects
360 cases non-TB subjects with lung disease and suspected TB subjects,who meet the standard respectively are divided average into different groups through a randomized and blind method. 180 non-TB subjects with lung disease are injected ESAT6-CFP10(10ug/ml) in left arm and TB-PPD in right arm. 180 non-TB subjects with lung disease are injected ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm. The study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.
干预措施: ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm (Biological)
结局指标
主要结局
Immune response of right arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in TB patients
时间窗: within 72h after injection
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally right arm (random injected ESAT6-CFP10 or PPD)
Immune response of right arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in non-TB subjects with lung disease
时间窗: within 72h after injection
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally right arm (random injected ESAT6-CFP10 or PPD)
Immune response of left arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in TB patients
时间窗: within 72h after injection
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally left arm (random injected ESAT6-CFP10 or PPD)
Immune response of left arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in non-TB subjects with lung disease
时间窗: within 72h after injection
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally left arm (random injected ESAT6-CFP10 or PPD)
次要结局
- Number of participants with Adverse Events(within 72h after injection two drug each participant)