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New treatment option for Tuberculosis
Official title A Novel Therapy With a 1-Month Ultrashort Regimen to Halt Progression From Latent Infection to Active Tuberculosis Among Close Contacts (The TB-YOUTH Study)
ClinicalTrials.gov ID: NCT06022146
What this study is testing
What is isoniazid and rifapentine?
isoniazid and rifapentine is an investigational medicine, being studied as a potential treatment for tuberculosis.
Also referred to as 1H3P3.
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
- This is a prospective, multi-center, open-label, cluster randomized controlled clinical trial conducted in school settings to estimate the non-inferiority effect of 1H3P3 compared with 3HR.
- 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 13 and older
You may be able to join if
- Aged ≥13 years and body weight ≥ 30 kg;
- School-registered individuals including:
- Currently attending junior / senior high school or university students;
- School staff members;
- Close contacts of active pulmonary TB index cases (confirmed or clinically diagnosed) within the school, defined by meeting both of the following:
You likely can't join if
- Current active TB disease (clinically or bacteriologically confirmed);
- Documented isoniazid/rifampicin resistance in the corresponding M. tuberculosis strain from the index case;
- Self-reported use of rifamycins (e.g., rifampicin, rifapentine) or isoniazid for \>14 consecutive days within the past 2 years;
- Prior completion of full-course of treatment for ATB or LTBI;
- Hypersensitivity or intolerance to rifamycins (rifapentine / rifampicin) or isoniazid;
- HIV positive serostatus or AIDS patients;
See the full eligibility criteria
- Aged ≥13 years and body weight ≥ 30 kg;
- School-registered individuals including:
- Currently attending junior / senior high school or university students;
- School staff members;
- Close contacts of active pulmonary TB index cases (confirmed or clinically diagnosed) within the school, defined by meeting both of the following:
- Teachers/students sharing the same classroom or dormitory with the index case;
- Exposure history: Prolonged sharing of enclosed space (\>4 hours total within 1 week) with the index case;
- Confirmed LTBI status through screening;
- Voluntary participation with signed informed consent form (for adults ≥18 years);
- Parental / guardian consent and co-signed informed consent form (for minors aged 13-17 years).
- Current active TB disease (clinically or bacteriologically confirmed);
- Documented isoniazid/rifampicin resistance in the corresponding M. tuberculosis strain from the index case;
- Self-reported use of rifamycins (e.g., rifampicin, rifapentine) or isoniazid for \>14 consecutive days within the past 2 years;
- Prior completion of full-course of treatment for ATB or LTBI;
- Hypersensitivity or intolerance to rifamycins (rifapentine / rifampicin) or isoniazid;
- HIV positive serostatus or AIDS patients;
- History of viral hepatitis (e.g., chronic hepatitis B, chronic hepatitis C) or liver cirrhosis;
- Liver dysfunction (TBil\>2.5mg/dL [43umol/L] or ALT / AST\>2ULN) or renal dysfunction.
- Current receiving immunosuppressive therapy or biological agents.
- Hematologic disorders with either PLT\<50×109/L or WBC\<3.0×109/L.
- Other conditions deemed unsuitable for TPT by investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Anshun, Guiyang, China
- Anshun, Guizhou, China
- Bijie, Guizhou, China
- Daozhen Klau and Hmong Autonomous County in Zun'yi, Guizhou, China
- Guiyang, Guizhou, China
- Liupanshui, Guizhou, China
- Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
- Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
- Qiannan, Guizhou, China
- Tongren, Guizhou, China
- Zunyi, Guizhou, China
- Dalian, Liaoning, China
- Shanghai, Shanghai Municipality, China
- Bijie, China
- Guiyang, China
- Qiandongnan Miao and Dong Autonomous Region, China
- Qiannan, China
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, 13 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anshun, Guiyang, China; Anshun, Guizhou, China; Bijie, Guizhou, China; Daozhen Klau and Hmong Autonomous County in Zun'yi, Guizhou, China; Guiyang, Guizhou, China; Liupanshui, Guizhou, China and 11 more location(s). 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.