NCT06022146Toboroz3. fázis
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)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 14.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 3520 (tervezett)
- Első benyújtás
- 2023. márc. 23.
- Kezdés
- 2023. szept. 1.
- Elsődleges befejezés
- 2026. szept. 1.
- Fő szponzor
- Huashan Hospital
- Betegségek
- Tuberkulózis
- NCT-szám
- NCT06022146
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Tervezett résztvevők: 3520
- 2023. szept. 1. és az elsődleges befejezés (2026. szept. 1.) között
- 64 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Prior completion of full-course of treatment for ATB or LTBI;
- Current receiving immunosuppressive therapy or biological agents.
Más betegség
- Current active TB disease (clinically or bacteriologically confirmed);
- Documented isoniazid/rifampicin resistance in the corresponding M. tuberculosis strain from the index case;
- 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;
- Other conditions deemed unsuitable for TPT by investigators.
Laborértékek
- Liver dysfunction (TBil>2.5mg/dL [43umol/L] or ALT / AST>2ULN) or renal dysfunction.
- Hematologic disorders with either PLT<50×109/L or WBC<3.0×109/L.
Egyéb
- Self-reported use of rifamycins (e.g., rifampicin, rifapentine) or isoniazid for >14 consecutive days within the past 2 years;
Kiket keres a vizsgálat
- 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).
Életkor a regiszterben: 13 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (64)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| People's Hospital of Guanling | Anshun | Kína | Toboroz |
| People's Hospital of Zhenning | Anshun | Kína | Toboroz |
| People's Hospital of Pingba District | Anshun | Kína | Toboroz |
| People's Hospital of Xixiu District | Anshun | Kína | Toboroz |
| People's Hospital of Ziyun | Anshun | Kína | Toboroz |
| People's Hospital of Puding | Anshun | Kína | Toboroz |
| People's Hospital of Hezhang | Bijie | Kína | Toboroz |
| People's Hospital of Qianxi | Bijie | Kína | Toboroz |
| People's Hospital of Dafang Town | Bijie | Kína | Toboroz |
| People's Hospital of Nayong | Bijie | Kína | Toboroz |
| People's Hospital of Weining | Bijie | Kína | Toboroz |
| People's Hospital of Zhijin | Bijie | Kína | Toboroz |
| 3rd People's Hospital of Bijie | Bijie | Kína | Toboroz |
| Dalian Public Health Clinical Center | Dalian | Kína | Toboroz |
| People's Hospital of Daozhen Klau and Hmong autonomous county | Daozhen Klau and Hmong Autonomous County in Zun'yi | Kína | Toboroz |
| People's Hospital of Huaxi District | Guiyang | Kína | Toboroz |
| People's Hospital of Baiyun District | Guiyang | Kína | Toboroz |
| Chinese Medicine Hospital of Qingzhen | Guiyang | Kína | Toboroz |
| People's Hospital of Wudang District | Guiyang | Kína | Toboroz |
| People's Hospital of Xifeng | Guiyang | Kína | Toboroz |
| People's Hospital of Kaiyang | Guiyang | Kína | Toboroz |
| People's Hospital of Xiuwen | Guiyang | Kína | Toboroz |
| Guiyang Public Health Treatment Center | Guiyang | Kína | Toboroz |
| Liuzhi Special District | Liupanshui | Kína | Toboroz |
| People's Hospital of Shuicheng District, Liupanshui City | Liupanshui | Kína | Toboroz |
| People's Hospital of Panzhou | Liupanshui | Kína | Toboroz |
| Third People's Hospital of Liupanshui | Liupanshui | Kína | Toboroz |
| Second People's Hospital of Liupanshui City | Liupanshui | Kína | Toboroz |
| People's Hospital of Cengong | Qiandongnan Miao and Dong Autonomous Prefecture | Kína | Toboroz |
| People's Hospital of Congjiang | Qiandongnan Miao and Dong Autonomous Prefecture | Kína | Toboroz |
| People's Hospital of Jianhe | Qiandongnan Miao and Dong Autonomous Region | Kína | Toboroz |
| First People's Hospital of Kaili | Qiandongnan Miao and Dong Autonomous Region | Kína | Toboroz |
| People's Hospital of Rongjiang | Qiandongnan Miao and Dong Autonomous Region | Kína | Toboroz |
| People's Hospital of Jinping | Qiandongnan Miao and Dong Autonomous Region | Kína | Toboroz |
| People's Hospital of Tianzhu | Qiandongnan Miao and Dong Autonomous Region | Kína | Toboroz |
| People's Hospital of Liping | Qiandongnan Miao and Dong Autonomous Region | Kína | Toboroz |
| People's Hospital of Danzhai | Qiandongnan Miao and Dong Autonomous Region | Kína | Toboroz |
| People's Hospital of Zhenyuan | Qiandongnan Miao and Dong Autonomous Region | Kína | Toboroz |
| People's Hospital of Sansui | Qiandongnan Miao and Dong Autonomous Region | Kína | Toboroz |
| People's Hospital of Leishan | Qiandongnan Miao and Dong Autonomous Region | Kína | Toboroz |
| People's Hospital of Majiang | Qiandongnan Miao and Dong Autonomous Region | Kína | Toboroz |
| People's Hospital of Taijiang | Qiandongnan Miao and Dong Autonomous Region | Kína | Toboroz |
| People's Hospital of Huangping | Qiandongnan Miao and Dong Autonomous Region | Kína | Toboroz |
| People's Hospital of Shibing | Qiandongnan Miao and Dong Autonomous Region | Kína | Toboroz |
| First People's Hospital of Fuquan | Qiannan | Kína | Toboroz |
| People's Hospital of Libo | Qiannan | Kína | Toboroz |
| People's Hospital of Luodian | Qiannan | Kína | Toboroz |
| People's Hospital of Changshun | Qiannan | Kína | Toboroz |
| Huashan Hospital | Shanghai | Kína | Toboroz |
| People's Hospital of Wanshan District | Tongren | Kína | Toboroz |
| People's Hospital of Renhuai | Zunyi | Kína | Toboroz |
| Zunyi Infectious Disease Hospital | Zunyi | Kína | Toboroz |
| People's Hospital of Suiyang | Zunyi | Kína | Toboroz |
| Guizhou Aerospace Hospital | Zunyi | Kína | Toboroz |
| People's Hospital of Xishui | Zunyi | Kína | Toboroz |
| People's Hospital of Wuchuan Klau and Hmong autonomous county | Zunyi | Kína | Toboroz |
| People's Hospital of Bozhou District | Zunyi | Kína | Toboroz |
| People's Hospital of Tongzi | Zunyi | Kína | Toboroz |
| People's Hospital of Chishui | Zunyi | Kína | Toboroz |
| People's Hospital of Zhengan | Zunyi | Kína | Toboroz |
| People's Hospital of Honghuagang District | Zunyi | Kína | Toboroz |
| People's Hospital of Meitan | Zunyi | Kína | Toboroz |
| People's Hospital of Yuqing | Zunyi | Kína | Toboroz |
| People's Hospital of Fenggang | Zunyi | Kína | Toboroz |
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