Shorter TB treatment: a 4-Month regimen put to the test
NCT ID NCT06727864
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 270 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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20 to 99 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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E-DA Healthcare Group
RECRUITINGKaohsiung City, Yanchao, 82445, Taiwan
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Far Eastern Memorial Hospital
RECRUITINGNew Taipei City, Bangiao, 220, Taiwan
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Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITINGKaohsiung City, 80756, Taiwan
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Kaohsiung Veterans General Hospital
RECRUITINGKaohsiung City, 813, Taiwan
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Linkou Chang Gung Memorial Hospital
RECRUITINGTaoyuan City, 333, Taiwan
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National Taiwan University Hospital
RECRUITINGTaipei, Taiwan
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Taichung Hospital
RECRUITINGTaichung, West, 199, Taiwan
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Taipei Veterans General Hospital
RECRUITINGTaipei, 112, Taiwan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can simple sputum and urine tests catch tuberculosis earlier?
- A single swab, two diseases: rapid test takes on TB and COVID-19
- Can HIV status change TB treatment success? a zambian study investigates
- Beyond TB: could a deeper diagnostic look uncover hidden lung diseases?
- Can a new patient cohort unlock the secrets of TB treatment success?
- Lung damage after TB: a new study tests whether rehabilitation can restore breathing and quality of life