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New treatment option for Pulmonary Tuberculosis
Official title Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter, Randomized, Active-controlled, Trial
ClinicalTrials.gov ID: NCT06727864
What this study is testing
What is 4-month regimen (2HERZ/2HRE)?
4-month regimen (2HERZ/2HRE) is an investigational medicine, being studied as a potential treatment for pulmonary tuberculosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Tuberculosis remains an important global health problem, and the world is currently not on track to end the TB epidemic by 2030. With the concerted efforts of the government and medical community, the incidence of TB in Taiwan has gradually decreased, however, Taiwan remains an endemic area for TB.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 99
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New Taipei City, Bangiao, Taiwan
- Taichung, West, Taiwan
- Kaoshiung, Yanchao, Taiwan
- Kaohsiung City, Taiwan
- Taipei, Taiwan
- Taoyuan City, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Taipei City, Bangiao, Taiwan; Taichung, West, Taiwan; Kaoshiung, Yanchao, Taiwan; Kaohsiung City, Taiwan; Taipei, Taiwan; Taoyuan City, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.