Condition: Tuberculosis · Sponsor: Chengdu CoenBiotech Co., Ltd
This study is a randomized, blinded, active-controlled clinical trial to evaluate the effectiveness and safety of EEC in the diagnosis of Mycobacterium tuberculosis infection in people aged 3 years and above. Methods: In study 1, the marketed recombinant Mycobacterium tuberculosis fusion protein (EC) was used as a control drug in people aged 3 to 64 years. The sensitivity of EEC in participants with tuberculosis and the specificity in healthy participants and patients with non-tuberculous lung diseases were evaluated compared with recombinant Mycobacterium tuberculosis fusion protein (EC). The clinical positivity criteria of EEC were verified, and the consistency of the two detection methods, as well as the safety of EEC, were evaluated. Study 2: Triple-negative people aged 18 and above (negative in EEC, TB-PPD, and IGRA tests) were screened out from the community population and vaccinated with BCG. EEC and TB-PPD double-arm skin tests were performed 12 weeks after vaccination to evaluate whether there was a significant difference in the negative rate of EEC compared with TB-PPD after BCG vaccination in the triple-negative population. Study 3: A multicenter, positive-controlled, non-inferiority trial design was used for people aged 65 years and above, and the research hypothesis was independently tested to verify the non-inferiority of the sensitivity of this product in tuberculosis patients in this age group compared with IGRA and TB-PPD, as well as the consistency of the…
This description comes directly from the study's public registry record.
Naihui Chu，PhD · 86+13611326573 · dongchu1994@sina.com
Shanling Chen, Master · 86+18008008240 · chen.shanling@coenbiotech.com
Always discuss trial participation with your own doctor first.
| Beijing Chest Hospital | Beijing, Beijing Municipality, China | Recruiting |
| Changsha Center Hospital | Hunan, Changsha, China | Recruiting |
| LiuZhou People's Hospital | Liuzhou, Guangxi, China | Recruiting |
| The First Affiliated Hospital of Xinxiang Medical College | Xinxiang, Henan, China | Not Yet Recruiting |
| Wuhan Pulmonary Hospital | Wuhan, Hubei, China | Recruiting |
| Wuhan Central Hospital | Wuhan, Hubei, China | Recruiting |
| Yichang Central People's Hospital | Yichang, Hubei, China | Recruiting |
| Public health clinical center of chengdu | Chengdu, Sichuan, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07152639