[Translation] A randomized, blinded, and similar product-controlled phase II clinical trial to explore the skin test application dose of recombinant Mycobacterium tuberculosis fusion protein (EEC) in people aged 18 to 65 years old
主要目的:
1. 评价不同剂量 EEC 在健康人群、 肺结核病患者和非结核性肺部疾病患者人群中的安全性。
2. 初步确定 EEC 的阳性诊断标准;
3. 确定 EEC 的最佳应用剂量。
次要目的:
1. 不同剂量 EEC、对照 EC 两种检测试剂在 18~65 岁肺结核病患者中的诊断一致性;
2. 不同剂量 EEC、对照 EC 两种检测试剂在 18~65 岁健康人群、非结核性肺部疾病患者中诊断一致性;
3. 在健康人群、肺结核病患者和非结核性肺部疾病患者中,分别评价不同剂量EEC、对照 EC 与 QFT 检测结果的一致性。
[Translation] Main objectives:
1. To evaluate the safety of different doses of EEC in healthy people, patients with pulmonary tuberculosis and patients with non-tuberculous lung diseases.
2. To preliminarily determine the positive diagnostic criteria for EEC;
3. To determine the optimal application dose of EEC.
Secondary objectives:
1. To evaluate the diagnostic consistency of different doses of EEC and control EC in patients with pulmonary tuberculosis aged 18-65 years;
2. To evaluate the diagnostic consistency of different doses of EEC and control EC in healthy people aged 18-65 years and patients with non-tuberculous lung diseases;
3. To evaluate the consistency of different doses of EEC, control EC and QFT test results in healthy people, patients with pulmonary tuberculosis and patients with non-tuberculous lung diseases.