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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

3,520

participants targeted

Target at P75+ for phase_3

Timeline

1mo left

Started Sep 2023

Typical duration for phase_3

Geographic Reach

1 country

66 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

Study Progress98%

Sep 2023Sep 2026

First Submitted

Initial submission to the registry

March 23, 2023

Completed

5 months until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed

Same day until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

March 23, 2023

Last Update Submit

July 13, 2026

Conditions

Tuberculosis Latent Tuberculosis

Keywords

latent tuberculosisTPTactive screening

Outcome Measures

Primary Outcomes (1)

Cumulative incidence of active tuberculosis (TB) over 24 months
The primary endpoint is a composite of bacteriologically confirmed or clinically diagnosed active TB within 24 months after randomization. Bacteriologically confirmed TB is defined as M. tuberculosis detection by sputum culture and/or molecular assay (e.g., GeneXpert MTB/RIF). Clinically diagnosed TB requires the presence of ≥2 objective clinical symptoms (cough ≥2 weeks, fever, night sweats, weight loss \>10%, or hemoptysis) plus chest imaging findings highly suggestive of active TB, after exclusion of alternative diagnoses. This measure will be used to assess the non-inferiority of the 1H3P3 regimen compared to the 3HR regimen.
up to 24 months after randomization

Secondary Outcomes (6)

Proportion of participants with adverse events (AEs) and serious adverse events (SAEs)
from first dose to one month after treatment completion
Incidence of treatment discontinuation attributable to AEs
During the treatment course period (up to 1 month for 1H3P3 arm and up to 3 months for 3HR arm).
Treatment completion rate.
up to 16 weeks from randomization
All-cause mortality.
up to 24 months after randomization
Acquired drug resistance
At time of active TB diagnosis, up to 24 months post-randomization.
+1 more secondary outcomes

Other Outcomes (1)

Patient-Reported Outcome (PRO) - Health-related Quality of Life (Exploratory)
From baseline up to 1 month post-treatment completion

Study Arms (2)

1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month

EXPERIMENTAL

12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month

Drug: isoniazid and rifapentine

3HR regimen of isoniazid and rifampicin once daily for three months

ACTIVE COMPARATOR

3HR regimen of isoniazid and rifampicin once daily for three months

Drug: Rifampin and Isoniazid

Interventions

isoniazid and rifapentineDRUG

12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for 4 weeks

Also known as: 1H3P3

1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month

Rifampin and IsoniazidDRUG

3HR regimen of isoniazid and rifampicin once daily for three months

Also known as: 3HR

3HR regimen of isoniazid and rifampicin once daily for three months

Eligibility Criteria

Age13 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Aged ≥13 years and body weight ≥ 30 kg;
School-registered individuals including:
Currently attending junior / senior high school or university students;
School staff members;
Close contacts of active pulmonary TB index cases (confirmed or clinically diagnosed) within the school, defined by meeting both of the following:
Teachers/students sharing the same classroom or dormitory with the index case;
Exposure history: Prolonged sharing of enclosed space (\>4 hours total within 1 week) with the index case;
Confirmed LTBI status through screening;
Voluntary participation with signed informed consent form (for adults ≥18 years);
Parental / guardian consent and co-signed informed consent form (for minors aged 13-17 years).

You may not qualify if:

Current active TB disease (clinically or bacteriologically confirmed);
Documented isoniazid/rifampicin resistance in the corresponding M. tuberculosis strain from the index case;
Self-reported use of rifamycins (e.g., rifampicin, rifapentine) or isoniazid for \>14 consecutive days within the past 2 years;
Prior completion of full-course of treatment for ATB or LTBI;
Hypersensitivity or intolerance to rifamycins (rifapentine / rifampicin) or isoniazid;
HIV positive serostatus or AIDS patients;
History of viral hepatitis (e.g., chronic hepatitis B, chronic hepatitis C) or liver cirrhosis;
Liver dysfunction (TBil\>2.5mg/dL \[43umol/L\] or ALT / AST\>2ULN) or renal dysfunction.
Current receiving immunosuppressive therapy or biological agents.
Hematologic disorders with either PLT\<50×109/L or WBC\<3.0×109/L.
Other conditions deemed unsuitable for TPT by investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Huashan Hospitallead

Study Sites (66)

People's Hospital of Ziyun

Anshun, Guiyang, China

RECRUITING

People's Hospital of Guanling

Anshun, Guizhou, China

RECRUITING

People's Hospital of Pingba District

Anshun, Guizhou, China

RECRUITING

People's Hospital of Puding

Anshun, Guizhou, China

RECRUITING

People's Hospital of Xixiu District

Anshun, Guizhou, China

RECRUITING

People's Hospital of Zhenning

Anshun, Guizhou, China

RECRUITING

People's Hospital of Hezhang

Bijie, Guizhou, China

RECRUITING

People's Hospital of Qianxi

Bijie, Guizhou, China

RECRUITING

People's Hospital of Qianxi

Bijie, Guizhou, China

RECRUITING

People's Hospital of Weining

Bijie, Guizhou, China

RECRUITING

People's Hospital of Zhijin

Bijie, Guizhou, China

RECRUITING

People's Hospital of Daozhen Klau and Hmong autonomous county

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

RECRUITING

Guiyang Public Health Treatment Center

Guiyang, Guizhou, China

RECRUITING

People's Hospital of Baiyun District

Guiyang, Guizhou, China

RECRUITING

People's Hospital of Huaxi District

Guiyang, Guizhou, China

RECRUITING

People's Hospital of Kaiyang

Guiyang, Guizhou, China

RECRUITING

People's Hospital of Wudang District

Guiyang, Guizhou, China

RECRUITING

People's Hospital of Xifeng

Guiyang, Guizhou, China

RECRUITING

People's Hospital of Xiuwen

Guiyang, Guizhou, China

RECRUITING

Liuzhi Special District

Liupanshui, Guizhou, China

RECRUITING

People's Hospital of Panzhou

Liupanshui, Guizhou, China

RECRUITING

People's Hospital of Shuicheng District, Liupanshui City

Liupanshui, Guizhou, China

RECRUITING

Second People's Hospital of Liupanshui City

Liupanshui, Guizhou, China

RECRUITING

Third People's Hospital of Liupanshui

Liupanshui, Guizhou, China

RECRUITING

People's Hospital of Cengong

Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China

RECRUITING

People's Hospital of Congjiang

Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China

RECRUITING

First People's Hospital of Kaili