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Can a 4-Month TB regimen work as well as 6 months?

NCT ID NCT06153069

Disease control Sponsor: Huashan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether people with asymptomatic tuberculosis (TB) can be treated effectively with a shorter course of standard antibiotics—17 weeks instead of the usual 6 months. Researchers will compare the shorter regimen to standard treatment in 426 participants in China. The goal is to see if the shorter course can achieve similar cure rates without increasing the risk of relapse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
isoniazid, rifampicin, pyrazinamide, ethambutol, rifapentine, moxifloxacin
What this could lead to
If successful, this could shorten tuberculosis treatment from the standard 6 months to about 4 months, making it easier for patients to complete therapy and reducing the burden on healthcare systems.
What could go wrong
This is a Phase 4 trial, but it focuses on asymptomatic TB, which is less studied. Shorter treatment may increase relapse risk, and results may not apply to symptomatic TB or other populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 426 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

latent tuberculosis infection tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tuberculosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Chest Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 200040, China

  • Huashan Hospital of Fudan University

    ACTIVE_NOT_RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

  • Liupanshui City Third People's Hospital

    RECRUITING

    Liupanshui, Guizhou, China

  • Nayong County People's Hospital

    RECRUITING

    Nayong, Guizhou, 200040, China

  • The First People's Hospital of Linping District, Hangzhou

    RECRUITING

    Hangzhou, Zhejiang, China

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