Asymptomatic TB With Innovative Modified Short-course Regimens (SWIFT)

Clinical Efficacy of a Short-course Regimen for Asymptomatic Tuberculosis in China

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.

Study Overview

• Status: Recruiting
• Conditions: Tuberculosis
• Intervention / Treatment: Drug: Four-month regimen; Drug: Standard regimen; Drug: Three-month regimen

Detailed Description

This study is a prospective, open-label, multicenter randomized controlled trial. The randomization process will use centralized stratified block randomization to minimize bias across province of participating sites.

Asymptomatic tuberculosis individuals included in the study will be randomly assigned in a 1:1:1 ratio to three groups: Standard Regimen Group, Four-month Regimen Group or Three-month Regimen Group. The standard regimen consists of rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E) for 8 weeks, followed by rifampicin and isoniazid for an additional 18 weeks. The four-month regimen group follows the same regimen as the standard regimen group for the initial 8 weeks, followed by a continuation phase of daily rifampin (R) and isoniazid (H) for 9 weeks. The three-month regimen consists of high-dose rifapentine (P), isoniazid (H), pyrazinamide (Z), and moxifloxacin (M) for 8 weeks, followed high-dose Rifapentine (P), isoniazid (H), and moxifloxacin (M) for 5 weeks. For individuals in the four-month and the three-month regimen group, the treatment response will be evaluated at the end of the treatment phase. 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.

• Study Type: Interventional
• Enrollment (Estimated): 426
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yang Li, Dr.; Phone Number: 8123 (086)18817583793; Email: y_li11@fudan.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 200040
      • Recruiting
      • Beijing Chest Hospital, Capital Medical University
      • Contact: Jin Shi; Phone Number: Jin Shi; Email: 17888811023@163.com
  • Guizhou
    • Liupanshui, Guizhou, China
      • Recruiting
      • Liupanshui City Third People's Hospital
      • Contact: Xiaohong Guo; Phone Number: 13688588822; Email: 354269949@qq.com
    • Nayong, Guizhou, China, 200040
      • Recruiting
      • Nayong County People's Hospital
      • Contact: Qili Liu; Phone Number: 15286570489; Email: tginkstone@gmail.com
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Active, not recruiting
      • Huashan Hospital of Fudan University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The First People's Hospital of Linping District, Hangzhou
      • Contact: Xiaoqiang Zhang; Phone Number: 13372511070; Email: 16857019@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Age between 14 to 80 years;
• 2. Male or female;
• 3. Willing to provide signed informed consent, or parental consent and participant assent;
• 4. Individuals with respiratory tract specimen (including sputum/bronchoalveolar lavage fluid/lung tissue) positive for acid-fast bacilli smear/culture/molecular amplification for M. tuberculosis;
• 5. 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;
• 6. If non-menopausal woman, agree to use or have used effective contraception during treatment.

Exclusion Criteria:

• 1. Combined extrapulmonary tuberculosis;
• 2. Induviduals with extensive lesion (lesion involvement exceeding 50% or the aggregate diameter of all cavities exceeding 6 cm) ;
• 3. 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;
• 4. 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;
• 5. Hemoglobin is less than 70g/L, or platelet is less than 50*10^9/L;
• 6. Estimated Glomerular Filtration Rate (eGFR) is less than 30 mL/min/1.73m2;
• 7. Known allergic or intolerant to any of the study drugs;
• 8. Pregnant or breast-feeding;
• 9. Prior anti-TB treatment for more than one week in the past six months;
• 10.Known history of epilepsy, uncontrolled diabetes;
• 11.For HIV-positive subjects, T-lymphocyte (CD4 cell) counts less than 100 cells/mm3;
• 12. Unable to tolerant oral treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Four-month regimen; 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; 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.
Active Comparator: Standardized Regimen; 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; 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.
Experimental: Three-month regimen; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Favorable outcome rate in assessable and PP population	To compare the proportion of participants in assessable population and PP population achieving favorable outcomes at 78 weeks post-randomization.	At 78 weeks post-randomization
Relapse rate post-treatment	To compare the proportion of relapse rate post-treatment.	At 104 weeks post-randomization
The proportion of participants with sputum culture conversion	The proportion of participants with sputum culture conversion at 8 weeks post-randomization	At 8 weeks post-randomization
The proportion of grade 3 or greater adverse events	To evaluate the proportion of participants who experience grade 3 or greater adverse events.	From treatment initiation until two weeks after the last dose
Acquired drug resistance	The proportion of participants acquiring drug resistance during follow-up.	Post-treatment follow-up phase
Acceptability to regimens	The total score of acceptability in mITT population and PP population at the end of treatment.	At the end of treatment
The overall index score of quality of life	The overall index score of quality of life in mITT population and PP population at the end of treatment and at 78 weeks post-randomization.	At the end of treatment and at 78 weeks post-randomization
Community transmission risk	The community transmission risk in mITT and PP population.	From treatment initiation
Serious adverse events	Proportion of serious adverse events from the date of informed consent until completion of the final follow-up.	From informed consent through final follow-up

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Collaborators: University of Toronto
• Investigators: Principal Investigator: Wenhong Zhang, Dr., Huashan Hospital of Fudan University，Shanghai，China

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: shorter treatment; subclinical tuberculosis
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Health Care Quality, Access, and Evaluation; Therapeutics; Health Care Evaluation Mechanisms; Quality of Health Care; Epidemiologic Study Characteristics; Clinical Protocols
• Other Study ID Numbers: KY2023-715

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No