TB YOUTH - TB SYstemic Management Using One-month, Ultra-short TPT Regimen for ScHool Contacts
- Conditions
- TuberculosisLatent Tuberculosis
- Interventions
- Registration Number
- NCT06022146
- Lead Sponsor
- Huashan Hospital
- Brief Summary
This is a prospective, multi-center, open-label, cluster randomized controlled clinical trial conducted in school settings to estimate the non-inferiority effect of 1H3P3 compared with 3HR.
- Detailed Description
Background： Adolescents are susceptible to tuberculosis. Almost 1.1 million children (aged below 15 years) and another half a million older adolescents (15-19 years) become ill with TB every year. Approximately 5%-10% people infected with TB develop to active disease, which suggest that a great proportion of adolescents remain undiagnosed and unprotected. Undiagnosed cases and school-based transmission contribute to the burden of TB among adolescents. Closing the gap in targeted interventions for TB prevention in schools is essential to break the cycle of transmission and ensure the well-being of school-aged adolescents. However, TB preventive treatment targeted on adolescents are still lacking.
Method： This is a prospective, multicenter, open-label, non-inferiority, cluster randomized controlled clinical trial within the national tuberculosis control program of GuiZhou,China. Close contacts of school tuberculosis index cases are actively screened with QFT(QuantiFERON-TB Gold Plus), chest X-ray, pooled GeneXpert MTB/RIF test of sputum and symptoms. After ruling out active tuberculosis, LTBI students are enrolled to attend a non-inferiority, cluster randomized controlled clinical trial. The students will be given either 3HR or 1H3P3 regimen and followed for two years. Our primary endpoint is culture or GeneXpert MTB/RIF confirmed TB or clinically highly suggested TB. Assume ICC (interclass correlation coefficient) to be 0.05, and the the lost to follow-up rate is 10%, the study will need 1760 subjects per arm to provide 80% power to detect a 20% non-inferiority margin of primary endpoint between the two arms.
Discussion:
The effectiveness of contact investigation among adolescent students as a tool for improved tuberculosis control has not been established. The integration of ultra-short treatment regimens with active screening holds the potential to provide a comprehensive and effective strategy for tuberculosis prevention and control in school environments, which may help reform the national tuberculosis policy regarding adolescent TB.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2978
- Male or female, ≥13 years old, weighting ≥30kg;
- Students of junior middle school, high school or college, or school staff;
- In the scope of ATB case-driven screening delimited by local CDC;
- Positive in IGRA test and diagnosed as LTBI;
- Voluntary (together with his/her guardian for age under 18 years old) participant in trial and signed informed consent.
- Current clinical or sputum culture confirmed active tuberculosis
- Had continuously taken rifamycin (rifampicin, rifapentine etc.) or isoniazid for more than 14 days in the past 2 years
- Have completed a full course of treatment for ATB or LTBI
- Allergic or intolerant to rifamycin (rifapentine or rifampicin) or isoniazid
- HIV (human immunodeficiency virus) antibody positive or AIDS (Acquired immunodeficiency syndrome) patients
- History of viral hepatitis (e.g. chronic hepatitis B, chronic hepatitis C) or liver cirrhosis
- Liver dysfunction (Total bilirubin > 5mg/dL (43 umol/L) or Alanine aminotransferase > 2ULN or Aspartate aminotransferase > 2ULN) or renal dysfunction
- Current receiving immunosuppressive therapy or biological agents
- Blood system diseases or Platelet count<50×10^9/L or White Blood Cell count<3.0×10^9/L
- Other conditions deemed unsuitable for TPT by physician.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3HR regimen of isoniazid and rifampicin once daily for three months isoniazid and rifapentine 3HR regimen of isoniazid and rifampicin once daily for three months 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month Rifampin and Isoniazid 12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month
- Primary Outcome Measures
Name Time Method Number of participants with culture or GeneXpert MTB/RIF confirmed TB or clinically highly suggested TB up to 24 months after randomization The primary aim is to estimate the effectiveness non-inferiority of 1H3P3 to 3HR.
- Secondary Outcome Measures
Name Time Method Number of participants permanently withdrawal from medication for any reason. up to 24 months after randomization subjects may withdrawal from medication after serious adverse effect
N Number of participants complete the treatment. up to 24 months after randomization to compare the completion rates of the two regimens
All-cause mortality. up to 24 months after randomization subjects may withdrawal from this study because of death
Number of participants with drug resistance result. up to 24 months after randomization to study drug resistance condition of school TB endemic
Trial Locations
- Locations (46)
People's Hospital of Fenggang
🇨🇳Zunyi, Guizhou, China
People's Hospital of Honghuagang District
🇨🇳Zunyi, Guizhou, China
People's Hospital of Meitan
🇨🇳Zunyi, Guizhou, China
People's Hospital of Renhuai
🇨🇳Zunyi, Guizhou, China
People's Hospital of Suiyang
🇨🇳Zunyi, Guizhou, China
People's Hospital of Tongzi
🇨🇳Zunyi, Guizhou, China
People's Hospital of Panzhou
🇨🇳Liupanshui, Guizhou, China
People's Hospital of Hezhang
🇨🇳Bijie, Guizhou, China
People's Hospital of Qianxi
🇨🇳Bijie, Guizhou, China
People's Hospital of Weining
🇨🇳Bijie, Guizhou, China
People's Hospital of Zhijin
🇨🇳Bijie, Guizhou, China
People's Hospital of Daozhen Klau and Hmong autonomous county
🇨🇳Daozhen Klau and Hmong autonomous county in Zun'yi, Guizhou, China
People's Hospital of Danzhai
🇨🇳Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
Liuzhi Special District
🇨🇳Liupanshui, Guizhou, China
People's Hospital of Shuicheng District, Liupanshui City
🇨🇳Liupanshui, Guizhou, China
Second People's Hospital of Liupanshui City
🇨🇳Liupanshui, Guizhou, China
Third People's Hospital of Liupanshui
🇨🇳Liupanshui, Guizhou, China
People's Hospital of Cengong
🇨🇳Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
People's Hospital of Congjiang
🇨🇳Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
First People's Hospital of Kaili
🇨🇳Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
People's Hospital of Huangping
🇨🇳Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
People's Hospital of Jianhe
🇨🇳Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
People's Hospital of Jinping
🇨🇳Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
People's Hospital of Liping
🇨🇳Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
People's Hospital of Rongjiang
🇨🇳Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
People's Hospital of Sansui
🇨🇳Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
People's Hospital of Tianzhu
🇨🇳Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
People's Hospital of Shibing
🇨🇳Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
People's Hospital of Zhenyuan
🇨🇳Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
Poeple's Hospital of Leishan
🇨🇳Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
Guizhou Aerospace Hospital
🇨🇳Zunyi, Guizhou, China
People's Hospital of Bozhou District
🇨🇳Zunyi, Guizhou, China
People's Hospital of Chishui
🇨🇳Zunyi, Guizhou, China
People's Hospital of Wuchuan Klau and Hmong autonomous county
🇨🇳Zunyi, Guizhou, China
People's Hospital of Xishui
🇨🇳Zunyi, Guizhou, China
People's Hospital of Yuqing
🇨🇳Zunyi, Guizhou, China
People's Hospital of Zhengan
🇨🇳Zunyi, Guizhou, China
Zunyi Infectious Disease Hospital
🇨🇳Zunyi, Guizhou, China
Dalian Public Health Clinical Center
🇨🇳Dalian, Liaoning, China
Huashan Hospital
🇨🇳Shanghai, Shanghai, China
People's Hospital of Majiang
🇨🇳Qiandongnan Miao and Dong Autonomous Region, China
People's Hospital of Taijiang
🇨🇳Qiandongnan Miao and Dong Autonomous Region, China
3rd People's Hospital of Bijie
🇨🇳Bijie, China
People's Hospital of Dafang Town
🇨🇳Bijie, China
People's Hospital of Nayong
🇨🇳Bijie, China
Chinese Medicine Hospital of Qingzhen
🇨🇳Guiyang, China