NCT06153069

Brief Summary

This study is a randomized controlled trial among asymptomatic tuberculosis individuals aiming to assess whether the standard treatment duration can be shortened to 17 weeks without increasing the types or doses of anti-tuberculosis medications or 13 weeks with the high-dose rifapentine and moxifloxacin.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
426

participants targeted

Target at P75+ for phase_4

Timeline
30mo left

Started Nov 2025

Typical duration for phase_4

Geographic Reach
1 country

5 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

Study Progress16%
Nov 2025Nov 2028

First Submitted

Initial submission to the registry

November 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
2 years until next milestone

Study Start

First participant enrolled

November 21, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

November 22, 2023

Last Update Submit

February 8, 2026

Conditions

Tuberculosis

Keywords

subclinical tuberculosisshorter treatment

Outcome Measures

Primary Outcomes (1)

  • Favorable outcome rate in mITT pupulation

    To compare the proportion of participants in mITT population achieving favorable outcome at 78 weeks post-randomization.

    At 78 weeks post-randomization

Secondary Outcomes (9)

  • Favorable outcome rate in assessable and PP population

    At 78 weeks post-randomization

  • Relapse rate post-treatment

    At 104 weeks post-randomization

  • The proportion of participants with sputum culture conversion

    At 8 weeks post-randomization

  • The proportion of grade 3 or greater adverse events

    From treatment initiation until two weeks after the last dose

  • Acquired drug resistance

    Post-treatment follow-up phase

  • +4 more secondary outcomes

Study Arms (3)

Four-month regimen

EXPERIMENTAL

The four-month regimen consists of a 17-week course of standard daily first-line anti-tuberculosis therapy, administered as either fixed-dose combinations or separate bulk drugs, in accordance with the recommendations of Technical Guidelines for Tuberculosis Prevention and Control in China. The treatment comprises an intensive phase of 8 weeks with Isoniazid (H) , Rifampicin (R), Pyrazinamide (Z) and Ethambutol (E), followed by continuation phase of 9 weeks with HR. If the sputum culture remains positive at week 8, or if the radiological examination at the end of treatment still shows unclosed cavities, the continuation phase treatment will be extended by an additional 8 weeks.

Drug: Four-month regimen

Standardized Regimen

ACTIVE COMPARATOR

The standardized regimen consists of a 26-week course of standard daily first-line anti-tuberculosis therapy, administered as either fixed-dose combinations or separate bulk drugs, in accordance with the recommendations of Technical Guidelines for Tuberculosis Prevention and Control in China. The treatment comprises an intensive phase of 8 weeks with Isoniazid (H) , Rifampicin (R), Pyrazinamide (Z) and Ethambutol (E), followed by continuation phase of 18 weeks with HR.

Drug: Standard regimen

Three-month regimen

EXPERIMENTAL

Three-month regimen consists of two periods of 13-21 weeks. During the intensive phase (8 weeks), rifapentine 900 mg daily; moxifloxacin 400 mg daily; isoniazid 300 mg daily; pyrazinamide \<50.0kg 1000mg daily, 50.0-70.9kg 1500 mg daily, ≥71kg 2000mg daily. During the continuation phase (5 or 13 weeks based on the culture resultes and radiological manifestations), rifapentine 900 mg daily; moxifloxacin 400 mg daily; isoniazid 300 mg daily; All treatment is taken orally. For rifapentine administration, the daily dosage may be reduced to 600mg if intolerance occurs.

Drug: Three-month regimen

Interventions

Standard regimenDRUG

The standardized regimen consists of a 26-week course of standard daily first-line anti-tuberculosis therapy, administered as either fixed-dose combinations or separate bulk drugs, in accordance with the recommendations of Technical Guidelines for Tuberculosis Prevention and Control in China. The treatment comprises an intensive phase of 8 weeks with Isoniazid (H) , Rifampicin (R), Pyrazinamide (Z) and Ethambutol (E), followed by continuation phase of 18 weeks with HR.

Standardized Regimen
Four-month regimenDRUG

The four-month regimen consists of a 17-week course of standard daily first-line anti-tuberculosis therapy, administered as either fixed-dose combinations or separate bulk drugs, in accordance with the recommendations of Technical Guidelines for Tuberculosis Prevention and Control in China. The treatment comprises an intensive phase of 8 weeks with Isoniazid (H) , Rifampicin (R), Pyrazinamide (Z) and Ethambutol (E), followed by continuation phase of 9 weeks with HR. If the sputum culture remains positive at week 8, or if the radiological examination at the end of treatment still shows unclosed cavities, the continuation phase treatment will be extended by an additional 8 weeks.

Four-month regimen
Three-month regimenDRUG

Three-month regimen consists of two periods of 13-21 weeks. During the intensive phase (8 weeks), rifapentine 900 mg daily; moxifloxacin 400 mg daily; isoniazid 300 mg daily; pyrazinamide \<50.0kg 1000mg daily, 50.0-70.9kg 1500 mg daily, ≥71kg 2000mg daily. During the continuation phase (5 or 13 weeks based on the culture resultes and radiological manifestations), rifapentine 900 mg daily; moxifloxacin 400 mg daily; isoniazid 300 mg daily; All treatment is taken orally. For rifapentine administration, the daily dosage may be reduced to 600mg if intolerance occurs.

Three-month regimen

Eligibility Criteria

Age14 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age between 14 to 80 years;
  • \. Male or female;
  • \. Willing to provide signed informed consent, or parental consent and participant assent;
  • \. Individuals with respiratory tract specimen (including sputum/bronchoalveolar lavage fluid/lung tissue) positive for acid-fast bacilli smear/culture/molecular amplification for M. tuberculosis;
  • \. No unexplained TB-suggestive symptoms in the three months prior to screening, including cough lasting more than two weeks, night sweats, fever or weight loss;
  • \. If non-menopausal woman, agree to use or have used effective contraception during treatment.

You may not qualify if:

  • \. Combined extrapulmonary tuberculosis;
  • \. Induviduals with extensive lesion (lesion involvement exceeding 50% or the aggregate diameter of all cavities exceeding 6 cm) ;
  • \. Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones;
  • \. Individuals with impaired liver function (alanine transaminase \[ALT\] or total bilirubin \[TBIL\] more than 2.5 times the upper limit of normal) or combined with liver cirrhosis;
  • \. Hemoglobin is less than 70g/L, or platelet is less than 50\*10\^9/L;
  • \. Estimated Glomerular Filtration Rate (eGFR) is less than 30 mL/min/1.73m2;
  • \. Known allergic or intolerant to any of the study drugs;
  • \. Pregnant or breast-feeding;
  • \. Prior anti-TB treatment for more than one week in the past six months;
  • Known history of epilepsy, uncontrolled diabetes;
  • For HIV-positive subjects, T-lymphocyte (CD4 cell) counts less than 100 cells/mm3;
  • \. Unable to tolerant oral treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, 200040, China

RECRUITING

Liupanshui City Third People's Hospital

Liupanshui, Guizhou, China

RECRUITING

Nayong County People's Hospital

Nayong, Guizhou, 200040, China

RECRUITING

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200040, China

ACTIVE NOT RECRUITING

The First People's Hospital of Linping District, Hangzhou

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Wenhong Zhang, Dr.

    Huashan Hospital of Fudan University，Shanghai，China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Li, Dr.

CONTACT

(086)18817583793y_li11@fudan.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Division of Infectious Diseases

Study Record Dates

First Submitted

November 22, 2023

First Posted

December 1, 2023

Study Start

November 21, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN(5)