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Shorter TB treatment: a 4-Month regimen put to the test

NCT ID NCT06727864

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial is testing whether a 4-month treatment for drug-sensitive pulmonary tuberculosis works as well as the standard 6-month regimen. The study involves 270 adults with newly diagnosed TB. If the shorter course proves effective, it could make treatment easier to complete and help reduce the spread of TB.

What this could mean

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

Active substance
A 4-month anti-tuberculosis drug regimen (2HERZ/2HRE) compared to the standard 6-month regimen (2HERZ/4HRE)
What this could lead to
If successful, this could shorten TB treatment to 4 months, improving completion rates and reducing transmission.
What could go wrong
The shorter regimen may be less effective or have more side effects than the standard 6-month course. Results are not yet available.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 270 people

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

Started

Jan 2024

Expected to finish

Dec 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

20 to 99 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: * Newly diagnosed pulmonary tuberculosis patients combined with any of the following diagnostic conditions: * at least one set of sputum specimens is positive for Mycobacterium tuberculosis culture or TB PCR test; or * pathological and histological findings of typical tuberculosis manifestations; * clinical diagnosis and Physician determines the need for complete anti-tuberculosis treatment * Those who have had tuberculosis in the past and have been cured for at least three years can be included * Aged over 20 years old * Laboratory data at the time of inclusion in the study or within 14 days: * Serum or plasma glutamic acid pyruvate transaminase (ALT) value ≦ three times the upper limit of normal * Serum or plasma total bilirubin ≦ 2.5 times the upper limit of normal * Serum or plasma creatinine ≦ twice the upper limit of normal or creatinine clearance greater than 30 mL/min * Heme ≧7.0 g/Dl * Platelets ≧100,000/mm3 * Patient signs consent form * Patients who agree to join and cooperate with the county and city health bureau's urban treatment plan to ensure medication compliance. Exclusion Criteria: * The acid-fast smear of sputum or respiratory specimen is strongly positive (≥ 2+) * Chest X-ray or lung computed tomography combined with open lesions * Chest X-ray or lung computed tomography shows extensive lesions and the clinician judges that short-term treatment is not suitable * Simultaneous combination of intrapulmonary and extrapulmonary tuberculosis * People who are unable to take oral medications * People who have participated in this research * Have used anti-tuberculosis drugs for more than 14 days * A history of tuberculosis suspected or diagnosed as central nervous system tuberculosis, bone or joint tuberculosis, miliary tuberculosis or tuberculous pericarditis. * Known history of allergy or intolerance to this study drug * Patients with HIV infection, organ transplantation, and chronic renal failure * Long-term use of immunosuppressive drugs, including steroid use \>10mg/day (more than 30 consecutive days in the last three months) * Late exclusion: Mycobacterium tuberculosis is known to be resistant to any one or more of the following drugs: rifampin, isoniazid, ethambutol

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    8 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

  • E-DA Healthcare Group

    RECRUITING

    Kaohsiung City, Yanchao, 82445, Taiwan

  • Far Eastern Memorial Hospital

    RECRUITING

    New Taipei City, Bangiao, 220, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 80756, Taiwan

  • Kaohsiung Veterans General Hospital

    RECRUITING

    Kaohsiung City, 813, Taiwan

  • Linkou Chang Gung Memorial Hospital

    RECRUITING

    Taoyuan City, 333, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, Taiwan

  • Taichung Hospital

    RECRUITING

    Taichung, West, 199, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112, Taiwan

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