Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above

Latent Tuberculosis Infection Clinical Trial

Official title: A Multicenter, Randomized, Double-blind, Controlled Phase Ⅲ Trial of Recombinant Mycobacterium Tuberculosis Fusion Protein (EC) for the Diagnosis of Mycobacterium Tuberculosis Infection in 65-year-olds and Above

Status Recruiting

Clinical Trial Summary

A multicenter, randomized, blind, controlled trial design was used to select 240 tuberculosis (TB) patients, 120 non-tuberculous community population with other lung diseases, and 420 healthy community population without other lung diseases who met the inclusion criteria of this study. Blood supply specific gamma-interferon (T-SPOT) detection was performed first. Then, EC and Purified Protein derivation of tuberculin (TB-PPD) skin tests were performed on both arms, and the recorded results were observed. The first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases were included in the trial subgroup. Physical examination, blood routine, urine routine, liver and kidney function, and electrocardiogram tests were required before and 7 days after skin test after study number assignment.

Clinical Trial Description

A multicenter, randomized, blind, controlled trial design was adopted in this study. Subjects were enrolled in this clinical study after being qualified by physical examination, vital signs detection (body temperature, blood pressure, pulse and respiration), chest imaging (DR/CT) examination, mycobacterium tuberculosis etiology examination, HIV antibody detection, fasting blood glucose detection, etc. A total of 240 TB patients, 120 non-tuberculous community people with other lung diseases, and 420 healthy community people without other lung diseases were selected for inclusion in this study. Blood samples were collected for specific gamma-interferon (T-SPOT) detection, and then EC and TB-PPD in the same double arm skin test were used to observe and record the results. The first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases were included in the trial subgroup. Physical examination, blood routine, urine routine, liver and kidney function, and electrocardiogram tests were required before and 7 days after skin test after study number assignment. Vital signs (body temperature, blood pressure, pulse and respiration) were measured 30min and 24h after skin test, and body temperature was measured 48h and 72h after skin test. The skin reaction at the injection site was observed at 0min, 24h, 48h and 72h after skin test. ;

Related Conditions & MeSH terms

• Infections
• Latent Tuberculosis
• Latent Tuberculosis Infection
• Mycobacterium Infections
• Tuberculosis

• NCT number: NCT05899179
• Study type: Interventional
• Source: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
• Contact: Shuihua Lu, bachelor
• Phone: +86-18930811818
• Email: lushuihua66@126.com
• Status: Recruiting
• Phase: Phase 3
• Start date: August 3, 2023
• Completion date: October 31, 2025