Treatment for Latent Tuberculosis in Older Adults

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

This study is testing a new treatment for latent tuberculosis in older adults to see if it is safe and effective compared to other options.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 780 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. (industry)
• Locations: 8 sites (Bengbu, Anhui and 7 other locations)
• Trial ID: NCT05899179 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the efficacy of a recombinant Mycobacterium tuberculosis fusion protein in individuals aged 65 and older. It employs a multicenter, randomized, blind, controlled design, enrolling 240 tuberculosis patients, 120 individuals with other lung diseases, and 420 healthy participants. Participants undergo a series of tests including blood samples for gamma-interferon detection and skin tests to assess reactions to tuberculosis antigens. The study aims to monitor the safety and effectiveness of the treatment over a specified period.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 65 and older, including those diagnosed with tuberculosis or other lung diseases.

Not a fit: Patients under 65 years old or those without latent tuberculosis infection or other lung diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for older adults with latent tuberculosis infection.

How similar studies have performed: Previous studies have shown promise in using similar recombinant proteins for tuberculosis treatment, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 65 years old and above (≥ 65 years old), male or female, the subjects themselves voluntarily participate in this study, sign the informed consent form, and can understand and comply with the requirements of the trial protocol to participate in follow-up.
* Normal underarm body temperature (\< 37.3 °C);
* Tuberculosis patients: pulmonary tuberculosis patients and extrapulmonary tuberculosis patients diagnosed by researchers as confirmed cases of tuberculosis and clinically diagnosed cases. Refer to the "WS288-2017 Tuberculosis Diagnostic Criteria" to formulate the diagnostic criteria for pulmonary tuberculosis in this protocol, see Annex 1 for details; The diagnostic criteria for extrapulmonary tuberculosis were formulated with reference to the Technical Guidelines for Tuberculosis Prevention and Control in China (2021 edition of the Chinese Center for Disease Control and Prevention), as detailed in Annex 2.
* Non-tuberculous community population with other lung diseases: there is a clear lung disease, but the study physician can exclude pulmonary tuberculosis based on the patient's clinical manifestations, chest imaging and laboratory tests. Diagnostic criteria for their main types of nontuberculous other lung diseases can be found in Annex 3;
* Community healthy people without other lung diseases: those who have no history of tuberculosis, no suspicious symptoms of tuberculosis, no history of respiratory tract and recent respiratory symptoms, and no obvious abnormalities in both lungs on chest imaging (DR) examination; After consultation, there is no history of heart, liver, kidney, digestive tract, nervous system, or psychiatric abnormalities.

Exclusion Criteria:

* Combined with the following serious diseases, such as advanced tumors, acute exacerbation of chronic obstructive pulmonary disease, acute or progressive liver disease or kidney disease, decompensated stage of congestive heart failure, autoimmune diseases (except those who do not need to use immune agents in the stable period), primary immunodeficiency diseases, etc.;
* Those suffering from acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute conjunctivitis, acute otitis media, extensive skin diseases and allergies;
* Those with known or suspected (or high-risk occurrence possibility) immune impairment or abnormalities, such as those receiving immunosuppressants or immune booster therapy, receiving glucocorticoids, immunoglobulin preparations other than the gastrointestinal tract or blood products or plasma extracts within 1 month;
* Those who have positive human immunodeficiency virus (HIV) antibody test results;
* Those who are participating in other new drug clinical trials or have participated in any other new drug clinical trials within 3 months before this clinical trial;
* Fasting blood glucose ≥ 10mmol/L after drug control;
* Blood pressure range: systolic blood pressure ≥ 180 mmHg and (or) diastolic blood pressure ≥ 110 mmHg (those who take drugs are uncontrollable);
* Any situation that the investigator believes is poor adherence or may affect the evaluation of the trial.

Where this trial is running

Bengbu, Anhui and 7 other locations

• The First Affiliated Hospital of Bengbu Medical University — Bengbu, Anhui, China (RECRUITING)
• Anhui Chest Hospital — Hefei, Anhui, China (NOT_YET_RECRUITING)
• Guangzhou Municipal Hospital of Chest Medicine — Guangzhou, Guangdong, China (RECRUITING)
• The Third People's Hospital Of Shenzhen — Shenzhen, Guangdong, China (RECRUITING)
• LiuZhou People's Hospital — Liuzhou, Guangxi, China (RECRUITING)
• Changsha Central Hospital — Changsha, Hu Nan, China (RECRUITING)
• Wuxi NO.5 People's Hospital — Wuxi, Jiangsu, China (RECRUITING)
• Wuhan Institute for Tuberculosis Control — Wuhan, China (RECRUITING)

Study contacts

• Principal investigator: Shuihua Lu, bachelor — Shenzhen Third People's Hospital
• Study coordinator: Shuihua Lu, bachelor

Conditions: Latent Tuberculosis Infection