TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age13+
SponsorHuashan Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Aged ≥13 years and body weight ≥ 30 kg;
Currently attending junior / senior high school or university students;
School staff members;
Teachers/students sharing the same classroom or dormitory with the index case;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- isoniazid and rifapentine
- Rifampin and Isoniazid
Treatment groups
3,520 Participants
are divided into 2 treatment groupsLocations
47People's Hospital of Hezhang BijieGuizhou, China
People's Hospital of Qianxi BijieGuizhou, China
People's Hospital of Weining BijieGuizhou, China
People's Hospital of Zhijin BijieGuizhou, China
Sponsors and collaborators
Huashan Hospital
Lead sponsor
Source ClinicalTrials.gov