Tuberculosis Clinical Trial
Official title:
For Tuberculosis (TB) Clinical Auxiliary Diagnosis of Recombinant Mycobacterium Tuberculosis Allergen ESAT6 - CFP10 Dose of Certain Phase IIb Clinical Research
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.
Firstly,96 TB(Tuberculosis ) subjects which meet the standard respectively are divided into
different groups through a randomized, blind methods.
1. ESAT6-CFP10 （5μg/ml）in left arm；
2. ESAT6-CFP10 （5μg/ml）in right arm；
3. ESAT6-CFP10 （10μg/ml）in left arm；
4. 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 .
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