Tuberculosis preventive treatment among individuals with inactive tuberculosis suggested by untreated radiographic abnormalities: a community-based randomized controlled trial
Epidemiological and interventional studies have been rarely conducted among those with positive interferon-γ release assay (IGRA) results and radiologically inactive tuberculosis (TB) lesions on chest radiograph. This study aimed to estimate the effectiveness and safety of a six-week twice-weekly re...
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Taylor & Francis Group
2023-12-01
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| Series: | Emerging Microbes and Infections |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/22221751.2023.2169195 |
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| author | Haoran Zhang Henan Xin Ying Du Xuefang Cao Shouguo Pan Jianmin Liu Ling Guan Fei Shen Zisen Liu Bin Zhang Dakuan Wang Boxuan Feng Jiang Du Xueling Guan Yijun He Yongpeng He Zhanjiang Zhang Jiaoxia Yan Qi Jin Lei Gao |
| author_facet | Haoran Zhang Henan Xin Ying Du Xuefang Cao Shouguo Pan Jianmin Liu Ling Guan Fei Shen Zisen Liu Bin Zhang Dakuan Wang Boxuan Feng Jiang Du Xueling Guan Yijun He Yongpeng He Zhanjiang Zhang Jiaoxia Yan Qi Jin Lei Gao |
| author_sort | Haoran Zhang |
| collection | DOAJ |
| description | Epidemiological and interventional studies have been rarely conducted among those with positive interferon-γ release assay (IGRA) results and radiologically inactive tuberculosis (TB) lesions on chest radiograph. This study aimed to estimate the effectiveness and safety of a six-week twice-weekly regimen (rifapentine plus isoniazid) among this key population in rural China. First, chest digital radiography was conducted to screen individuals with inactive TB lesions. Then, the identified participants were further evaluated and eligible participants with IGRA-positive results were included in subsequent randomized controlled trial (RCT). Of 44,500 recruited residents, 2,988 presented with radiographically inactive TB among 43,670 with complete results of chest radiography and questionnaire, and 28.61% (855/2,988) tested IGRA positive. Subsequently, 677 eligible participants were included in this RCT (345 in the preventive treatment group and 332 in the untreated control group). The treatment completion rate was 80.00% (276/345), and 11.88% (41/345) participants reported side-effects including two cases of hepatotoxicity (0.58%, 2/345). In the intention-to-treat analysis, the cumulative incidence rate of microbiologically confirmed active TB during a two-year follow-up was 1.16 (95% confidence interval [CI]: 0.03–2.29) in the preventive treatment group and 1.51 (95% CI: 0.20–2.82) in the control group (p = .485). Subgroup analyses showed that the protective rates were 55.42% (95% CI: 10.33–93.07%) and 80.17% (95% CI: 25.36–97.96%) for participants with fibrosis and for those aged ≥60 years, respectively. The expected treatment effect was not observed for the six-week regimen in this study. Future studies with sufficient sample size are needed to verify our findings. |
| format | Article |
| id | doaj-art-b36afd49849444afb46acaeba77ad0d2 |
| institution | DOAJ |
| issn | 2222-1751 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Emerging Microbes and Infections |
| spelling | doaj-art-b36afd49849444afb46acaeba77ad0d22025-08-20T02:59:11ZengTaylor & Francis GroupEmerging Microbes and Infections2222-17512023-12-0112110.1080/22221751.2023.2169195Tuberculosis preventive treatment among individuals with inactive tuberculosis suggested by untreated radiographic abnormalities: a community-based randomized controlled trialHaoran Zhang0Henan Xin1Ying Du2Xuefang Cao3Shouguo Pan4Jianmin Liu5Ling Guan6Fei Shen7Zisen Liu8Bin Zhang9Dakuan Wang10Boxuan Feng11Jiang Du12Xueling Guan13Yijun He14Yongpeng He15Zhanjiang Zhang16Jiaoxia Yan17Qi Jin18Lei Gao19NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of ChinaNHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of ChinaNHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of ChinaNHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of ChinaCenter for Diseases Control and Prevention of Zhongmu County, Zhengzhou, People’s Republic of ChinaThe Sixth People’s Hospital of Zhengzhou, Zhengzhou, People’s Republic of ChinaThe Sixth People’s Hospital of Zhengzhou, Zhengzhou, People’s Republic of ChinaThe Sixth People’s Hospital of Zhengzhou, Zhengzhou, People’s Republic of ChinaCenter for Diseases Control and Prevention of Zhongmu County, Zhengzhou, People’s Republic of ChinaCenter for Diseases Control and Prevention of Zhongmu County, Zhengzhou, People’s Republic of ChinaCenter for Diseases Control and Prevention of Zhongmu County, Zhengzhou, People’s Republic of ChinaNHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of ChinaNHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of ChinaThe Sixth People’s Hospital of Zhengzhou, Zhengzhou, People’s Republic of ChinaNHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of ChinaNHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of ChinaCenter for Diseases Control and Prevention of Zhongmu County, Zhengzhou, People’s Republic of ChinaCenter for Diseases Control and Prevention of Zhongmu County, Zhengzhou, People’s Republic of ChinaNHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of ChinaNHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of ChinaEpidemiological and interventional studies have been rarely conducted among those with positive interferon-γ release assay (IGRA) results and radiologically inactive tuberculosis (TB) lesions on chest radiograph. This study aimed to estimate the effectiveness and safety of a six-week twice-weekly regimen (rifapentine plus isoniazid) among this key population in rural China. First, chest digital radiography was conducted to screen individuals with inactive TB lesions. Then, the identified participants were further evaluated and eligible participants with IGRA-positive results were included in subsequent randomized controlled trial (RCT). Of 44,500 recruited residents, 2,988 presented with radiographically inactive TB among 43,670 with complete results of chest radiography and questionnaire, and 28.61% (855/2,988) tested IGRA positive. Subsequently, 677 eligible participants were included in this RCT (345 in the preventive treatment group and 332 in the untreated control group). The treatment completion rate was 80.00% (276/345), and 11.88% (41/345) participants reported side-effects including two cases of hepatotoxicity (0.58%, 2/345). In the intention-to-treat analysis, the cumulative incidence rate of microbiologically confirmed active TB during a two-year follow-up was 1.16 (95% confidence interval [CI]: 0.03–2.29) in the preventive treatment group and 1.51 (95% CI: 0.20–2.82) in the control group (p = .485). Subgroup analyses showed that the protective rates were 55.42% (95% CI: 10.33–93.07%) and 80.17% (95% CI: 25.36–97.96%) for participants with fibrosis and for those aged ≥60 years, respectively. The expected treatment effect was not observed for the six-week regimen in this study. Future studies with sufficient sample size are needed to verify our findings.https://www.tandfonline.com/doi/10.1080/22221751.2023.2169195Latent tuberculosis infectionpreventive treatmentradiographically inactive tuberculosisfibrosisrandomized controlled trial |
| spellingShingle | Haoran Zhang Henan Xin Ying Du Xuefang Cao Shouguo Pan Jianmin Liu Ling Guan Fei Shen Zisen Liu Bin Zhang Dakuan Wang Boxuan Feng Jiang Du Xueling Guan Yijun He Yongpeng He Zhanjiang Zhang Jiaoxia Yan Qi Jin Lei Gao Tuberculosis preventive treatment among individuals with inactive tuberculosis suggested by untreated radiographic abnormalities: a community-based randomized controlled trial Emerging Microbes and Infections Latent tuberculosis infection preventive treatment radiographically inactive tuberculosis fibrosis randomized controlled trial |
| title | Tuberculosis preventive treatment among individuals with inactive tuberculosis suggested by untreated radiographic abnormalities: a community-based randomized controlled trial |
| title_full | Tuberculosis preventive treatment among individuals with inactive tuberculosis suggested by untreated radiographic abnormalities: a community-based randomized controlled trial |
| title_fullStr | Tuberculosis preventive treatment among individuals with inactive tuberculosis suggested by untreated radiographic abnormalities: a community-based randomized controlled trial |
| title_full_unstemmed | Tuberculosis preventive treatment among individuals with inactive tuberculosis suggested by untreated radiographic abnormalities: a community-based randomized controlled trial |
| title_short | Tuberculosis preventive treatment among individuals with inactive tuberculosis suggested by untreated radiographic abnormalities: a community-based randomized controlled trial |
| title_sort | tuberculosis preventive treatment among individuals with inactive tuberculosis suggested by untreated radiographic abnormalities a community based randomized controlled trial |
| topic | Latent tuberculosis infection preventive treatment radiographically inactive tuberculosis fibrosis randomized controlled trial |
| url | https://www.tandfonline.com/doi/10.1080/22221751.2023.2169195 |
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