Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      Firstly, 720 cases TB (Tuberculosis) participants who meet the standard respectively are
      divided into different groups through a randomized and blind method.

        1. ESAT6-CFP10(10ug/ml) in left arm

        2. 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.
    

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