NCT06153069 Asymptomatic TB With Innovative Modified Short-course Regimens
| NCT ID | NCT06153069 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Huashan Hospital |
| Condition | Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 426 participants |
| Start Date | 2025-11-21 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 426 participants in total. It began in 2025-11-21 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Wenhong Zhang, Dr.
PRINCIPAL INVESTIGATOR
Huashan Hospital of Fudan University，Shanghai，China
Frequently Asked Questions
Who can join the NCT06153069 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 80 Years, studying Tuberculosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06153069 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06153069 currently recruiting?
Yes, NCT06153069 is actively recruiting participants. Contact the research team at y_li11@fudan.edu.cn for enrollment information.
Where is the NCT06153069 trial being conducted?
This trial is being conducted at Beijing, China, Liupanshui, China, Nayong, China, Shanghai, China and 1 additional location.
Who is sponsoring the NCT06153069 clinical trial?
NCT06153069 is sponsored by Huashan Hospital. The principal investigator is Wenhong Zhang, Dr. at Huashan Hospital of Fudan University，Shanghai，China. The trial plans to enroll 426 participants.