Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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 .
    

Intervention name(s): 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm; 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm; 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm; 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): TB subjects and non-TB subjects with lung disease inject 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same person and different arm.; TB subjects and non-TB subjects with lung disease inject 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same person and different arm.; TB subjects and non-TB subjects with lung disease inject 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same person and different arm.; TB subjects and non-TB subjects with lung disease inject 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same person and different arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: diagnosis of Tuberculosis; ESAT6; CFP10; skin test; diagnostic test