Actively Recruiting

Phase 3
Age: 13Years +
All Genders
NCT06022146

TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts

Led by Huashan Hospital · Updated on 2025-12-22

3520

Participants Needed

47

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts

Who Can Participate

Age: 13Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 13 years or older and weighing at least 30 kg
  • Currently attending junior high school, senior high school, university, or working as school staff
  • Close contact with an active pulmonary TB index case in the school, defined as sharing the same classroom or dormitory and prolonged exposure (>4 hours total within 1 week)
  • Confirmed latent tuberculosis infection through screening
  • Voluntary participation with signed informed consent (for adults 18 years or older)
  • Parental or guardian consent with co-signed informed consent for minors aged 13-17 years
Not Eligible

You will not qualify if you...

  • Current active tuberculosis disease (clinically or bacteriologically confirmed)
  • Documented resistance to isoniazid or rifampicin in the TB strain from the index case
  • Use of rifamycins or isoniazid for more than 14 consecutive days within the past 2 years
  • Prior completion of full treatment for active or latent tuberculosis
  • Allergic or intolerant to rifamycins (rifapentine or rifampicin) or isoniazid
  • HIV positive or diagnosed with AIDS
  • History of viral hepatitis or liver cirrhosis
  • Liver dysfunction (total bilirubin >2.5 mg/dL or ALT/AST >2 times upper limit of normal) or kidney dysfunction
  • Currently receiving immunosuppressive therapy or biological agents
  • Blood disorders with platelet count below 50 x 10^9/L or white blood cell count below 3.0 x 10^9/L
  • Other conditions considered unsuitable for tuberculosis preventive treatment by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 47 locations

1

People's Hospital of Hezhang

Bijie, Guizhou, China

Actively Recruiting

2

People's Hospital of Qianxi

Bijie, Guizhou, China

Actively Recruiting

3

People's Hospital of Weining

Bijie, Guizhou, China

Actively Recruiting

4

People's Hospital of Zhijin

Bijie, Guizhou, China

Actively Recruiting

5

People's Hospital of Zhijin

Bijie, Guizhou, China

Actively Recruiting

6

People's Hospital of Daozhen Klau and Hmong autonomous county

Daozhen Klau and Hmong Autonomous County in Zun'yi, Guizhou, China

Actively Recruiting

7

Liuzhi Special District

Liupanshui, Guizhou, China

Actively Recruiting

8

People's Hospital of Panzhou

Liupanshui, Guizhou, China

Actively Recruiting

9

People's Hospital of Shuicheng District, Liupanshui City

Liupanshui, Guizhou, China

Actively Recruiting

10

Second People's Hospital of Liupanshui City

Liupanshui, Guizhou, China

Actively Recruiting

11

Third People's Hospital of Liupanshui

Liupanshui, Guizhou, China

Actively Recruiting

12

People's Hospital of Cengong

Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China

Actively Recruiting

13

People's Hospital of Congjiang

Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China

Actively Recruiting

14

First People's Hospital of Kaili

Qiandongnan Miao and Dong Autonomous Region, Guizhou, China

Actively Recruiting

15

People's Hospital of Danzhai

Qiandongnan Miao and Dong Autonomous Region, Guizhou, China

Actively Recruiting

16

People's Hospital of Huangping

Qiandongnan Miao and Dong Autonomous Region, Guizhou, China

Actively Recruiting

17

People's Hospital of Jianhe

Qiandongnan Miao and Dong Autonomous Region, Guizhou, China

Actively Recruiting

18

People's Hospital of Jinping

Qiandongnan Miao and Dong Autonomous Region, Guizhou, China

Actively Recruiting

19

People's Hospital of Liping

Qiandongnan Miao and Dong Autonomous Region, Guizhou, China

Actively Recruiting

20

People's Hospital of Rongjiang

Qiandongnan Miao and Dong Autonomous Region, Guizhou, China

Actively Recruiting

21

People's Hospital of Sansui

Qiandongnan Miao and Dong Autonomous Region, Guizhou, China

Actively Recruiting

22

People's Hospital of Shibing

Qiandongnan Miao and Dong Autonomous Region, Guizhou, China

Actively Recruiting

23

People's Hospital of Tianzhu

Qiandongnan Miao and Dong Autonomous Region, Guizhou, China

Actively Recruiting

24

People's Hospital of Zhenyuan

Qiandongnan Miao and Dong Autonomous Region, Guizhou, China

Actively Recruiting

25

Poeple's Hospital of Leishan

Qiandongnan Miao and Dong Autonomous Region, Guizhou, China

Actively Recruiting

26

Guizhou Aerospace Hospital

Zunyi, Guizhou, China

Actively Recruiting

27

People's Hospital of Bozhou District

Zunyi, Guizhou, China

Actively Recruiting

28

People's Hospital of Chishui

Zunyi, Guizhou, China

Actively Recruiting

29

People's Hospital of Fenggang

Zunyi, Guizhou, China

Actively Recruiting

30

People's Hospital of Honghuagang District

Zunyi, Guizhou, China

Actively Recruiting

31

People's Hospital of Meitan

Zunyi, Guizhou, China

Actively Recruiting

32

People's Hospital of Renhuai

Zunyi, Guizhou, China

Actively Recruiting

33

People's Hospital of Suiyang

Zunyi, Guizhou, China

Actively Recruiting

34

People's Hospital of Tongzi

Zunyi, Guizhou, China

Actively Recruiting

35

People's Hospital of Wuchuan Klau and Hmong autonomous county

Zunyi, Guizhou, China

Actively Recruiting

36

People's Hospital of Xishui

Zunyi, Guizhou, China

Actively Recruiting

37

People's Hospital of Yuqing

Zunyi, Guizhou, China

Actively Recruiting

38

People's Hospital of Zhengan

Zunyi, Guizhou, China

Actively Recruiting

39

Zunyi Infectious Disease Hospital

Zunyi, Guizhou, China

Actively Recruiting

40

Dalian Public Health Clinical Center

Dalian, Liaoning, China

Actively Recruiting

41

Huashan Hospital

Shanghai, Shanghai Municipality, China, 200040

Actively Recruiting

42

3rd People's Hospital of Bijie

Bijie, China

Actively Recruiting

43

People's Hospital of Dafang Town

Bijie, China

Actively Recruiting

44

People's Hospital of Nayong

Bijie, China

Actively Recruiting

45

Chinese Medicine Hospital of Qingzhen

Guiyang, China

Actively Recruiting

46

People's Hospital of Majiang

Qiandongnan Miao and Dong Autonomous Region, China

Actively Recruiting

47

People's Hospital of Taijiang

Qiandongnan Miao and Dong Autonomous Region, China

Actively Recruiting

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Research Team

R

Ruan Qiaoling, PhD

CONTACT

Z

Zhang Wenhong, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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