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 groupsSponsors and collaborators
Source ClinicalTrials.gov