A prophylactic intervention, randomized controlled study on latent Mycobacterium tuberculosis infection was carried out among rural resident population of 50-70 years old. After completion of the medication, a continuous 2-year observation will be carried out to obtain the incidence rateincidence of active tuberculosis in each group and to evaluate the protective effect of each intervention protocol. A comprehensive evaluation will be done on different intervention models in terms of the accomplishment rate of each protocol, adverse events, and compliance and, withdrawal of study population. Moreover, a long-term cohort observation will be maintained to explore the effective protective period of each intervention protocol.

  • General Information of Study
    • Overview
      Name Intervention cohort on rural residents (50-70 years old) with latent Mycobacterium tuberculosis infection
      Project Number CCC2018081402
      Website http://www.chictr.org.cn/index.aspx
      Investigators
      Gao Lei
      Institutions Institute of Pathogen Biology, Chinese Academy of Medical Sciences
      Contacts
      Zhang Haoran
      Funding the National Science and Technology Major Project of China,2014ZX10003001001
      Objectives A prophylactic intervention, randomized controlled study on latent Mycobacterium tuberculosis infection was carried out among rural resident population of 50-70 years old. After completion of the medication, a continuous 2-year observation will be carried out to obtain the incidence rateincidence of active tuberculosis in each group and to evaluate the protective effect of each intervention protocol.
      A comprehensive evaluation will be done on different intervention models in terms of the accomplishment rate of each protocol, adverse events, and compliance and, withdrawal of study population. Moreover, a long-term cohort observation will be maintained to explore the effective protective period of each intervention protocol.
      Start Date October 2015
      End Date December 2017
    • Study Design
      Number of Participants 21000
      Age Range ≥5 years old
      Geographic Distribution Zhongmu County, Henan Province
      General Information of Study Design and Sample Methods Cluster sampling was used and the downtown was divided into several groups. According to the sample size, we computed the number of the groups should be selected. All individuals in the selected group were investigated.
      Inclusion Criteria 1) 50-70 years old;
      2) Local household register population or external resident population has lived (> 6 months) and the population who are able to finish the whole study period;
      3) IGRA-positive population;
      4) Voluntary to sign the Informed Consent Form (ICF) and cooperate in completing the study content.
      Exclusion Criteria 1) Patients Populations with previous or current active tuberculosis, or with suspected active tuberculosis;
      2) Pregnant or lactating women or women preparing for pregnancy;
      3) History of prophylactic treatment with rifapentine;
      4) Liver dysfunction or impairment, Patients with renal insufficiency or degeneration;
      5)Positive in Human Immunodeficiency Virus (HIV) test (primary screening test), patients infected with Hepatitis B or C virus or with Hepatitis B or C;
      6)Patients with autoimmune diseases or undergoing the treatment with immunosuppressive agents;
      7) Patients addicted to drinking or drug users; Those without perfect capacity for act owing to mental disorders, deafmutism or disability, and those failing to cooperate in the test or failing to make a promise that they can complete the whole study period;
      8) Other conditions factors inapplicable for participation in this study as judged by the investigator.
    • Other Information
      Key Achievements (1) TB control among those high-risk populations were recognized by evaluating the characteristics and risk factors of TB infection and disease development. (2) This was the first prophylactic treatment on TB infection based on randomized controlled design in rural community. (3) Evaluating of safety and feasibility of short-course regimen would be benificial to further explore optimized TB infection therapy in China. (4) The safety and protective efficacy of two different short-course regimens were priliminarily obtained, and our results suggest that TB infection treatment regimens should be systematically evaluated in the settings lacking evidence before being applied in practice.
      Marker Papers Under review
      Strength An Intervention cohort on rural residents with latent Mycobacterium tuberculosis infection was firstly set in China, which would supply study base and scientific data for further strategy development of TB prevention.
      Weakness The follow-up bias was inevitable because of the long duration of follow-up, death and emigration.