For Tuberculosis (TB) Clinical Auxiliary Diagnosis of Recombinant Mycobacterium Tuberculosis Allergen ESAT6 - CFP10 Dose of Certain Phase IIb Clinical Research
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 192
- 主要终点
- the proportion of positive reaction within 72 hours after administered intradermally TB-PPD in TB patient
研究概览
简要总结
96 TB subjects and 96 non-TB subjects with lung disease who all meet the standard are divided into different groups through a randomized, blind methods.Every subject inject intradermally ESAT6-CFP10 and TB-PPD in different arms of the same person.Specific γ- IFN(gamma interferon) detection is needed before the injection.Evaluate the sensitivity (positive coincidence rate) ,the specificity (negative coincidence rate) and the coincidence rate of ESAT6-CFP10 in the tuberculosis patients and non-tuberculosis patients with lung diseases, and determine the optimal dose of ESAT6-CFP10 for clinical auxiliary diagnosis of tuberculosis.
详细描述
Firstly,96 TB(Tuberculosis ) subjects which meet the standard respectively are divided into different groups through a randomized, blind methods.
- ESAT6-CFP10 （5μg/ml）in left arm；
- ESAT6-CFP10 （5μg/ml）in right arm；
- ESAT6-CFP10 （10μg/ml）in left arm；
- ESAT6-CFP10 （10μg/ml）in right arm； Inject intradermally ESAT6-CFP10 and TB-PPD(tuberculin purified protein derivative ) in different arms of the same subject.For each of the participants in this clinical research, this study uniform that left arm inject a drug(ESAT6-CFP10 or TB - PPD) first, observe 30 min and no no obvious adverse reaction ,then another drug(ESAT6-CFP10 or TB - PPD) inject in right arm. We need draw blood to detect specific γ- IFN before the injection.Observe and record the vital signs (breathing, heart rate, blood pressure and temperature),the skin reaction diameter of injection site (flush and induration) , local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events.
Secondly, 96 non-TB subjects with lung disease are divided into different groups and the procedure are as the same as 96 TB subjects above .
Finally,we evaluate the sensitivity (positive coincidence rate) ,the specificity (negative coincidence rate) and the coincidence rate of ESAT6-CFP10 in the TB patients and non-tuberculosis patients with lung diseases,determine the optimal dose of ESAT6-CFP10 for clinical auxiliary diagnosis of tuberculosis,and further evaluate the safety of ESAT6-CFP10 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
- •of TB (tuberculosis ) subjects:
- •Diagnosis TB ;
- •18 to 65 years ;
- •Consent and signed informed consent forms(ICF) ;
- •Comply with follow-up .
排除标准
- •of TB (tuberculosis ) subjects:
- •advanced cancer, diabetes,copd in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc ;
- •Taking part in other clinical or within 3 months involved in any other clinical;
- •histories of allergy ;
- •in pregnancy or lactation;
- •In a mental illness ;
- •Any conditions affect the trial evaluation.
- •Inclusion Criteria of Non-tuberculosis subjects with lung disease :
- •Diagnosis non-tuberculosis subjects with lung disease ;
- •18 to 65 years ;
- •Consent and signed signed informed consent forms(ICF) ;
- •Comply with follow-up .
- •Exclusion Criteria of Non-tuberculosis subjects with lung disease :
- •advanced cancer, diabetes,copd in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc ;
- •Taking part in other clinical or within 3 months involved in any other clinical;
- •histories of allergy;
- •in pregnancy or lactation;
- •In a mental illness ;
- •Any conditions may affect the trial evaluation.
研究组 & 干预措施
TB subjects
96 TB subjects are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm.
干预措施: 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm (Biological)
TB subjects
96 TB subjects are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm.
干预措施: 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm (Biological)
TB subjects
96 TB subjects are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm.
干预措施: 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm (Biological)
TB subjects
96 TB subjects are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm.
干预措施: 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm (Biological)
non-TB subjects with lung disease
96 non-TB subjects with lung disease are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm.
干预措施: 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm (Biological)
non-TB subjects with lung disease
96 non-TB subjects with lung disease are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm.
干预措施: 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm (Biological)
non-TB subjects with lung disease
96 non-TB subjects with lung disease are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm.
干预措施: 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm (Biological)
non-TB subjects with lung disease
96 non-TB subjects with lung disease are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm.
干预措施: 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm (Biological)
结局指标
主要结局
the proportion of positive reaction within 72 hours after administered intradermally TB-PPD in TB patient
时间窗: within 72h after injection
we measure the size at 15min,24h,48h,72h after administered intradermally TB-PPD
Immune response of of ESAT6-CFP10 from the size of induration OR redness in non-TB patients with lung diseases
时间窗: within 72h after injection
we measure the size at 15min,24h,48h,72h after administered intradermally TB-PPD
The proportion of positive reaction after receiving specificity γ-IFN test in TB subjects and non-TB subjects with lung disease
时间窗: before administered intradermally
the diameter of induraton or redness within 72 hours after intradermal injection with ESAT6-CFP10 in TB patients
时间窗: within 72h after injection
we measure the size 15min,24h,48h,72h after administered intradermally ESAT6-CFP10
the proportion of positive reaction within 72 hours after intradermal injection with TB-PPD in non-TB patients with lung diseases
时间窗: within 72h after injection
we measure the size at 15min,24h,48h,72h after administered intradermally TB-PPD
次要结局
- the consistency between ESAT6-CFP10 and γ-IFN in TB subjects and non-TB subjects with lung disease(within 72h after injection)
- the consistency between TB-PPD and γ-IFN in TB subjects and non-TB subjects with lung disease(within 72h after injection)
- the consistency between ESAT6-CFP10 and TB-PPD in TB subjects and non-TB subjects with lung disease(within 72h after injection)
- the occurrence of adverse events within 72 hours after injection in TB subjects and non-TB subjects with lung disease(within 72h after injection two drugs)