TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts

ConditionsTuberculosis Latent Tuberculosis

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

isoniazid and rifapentine
Drug
12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for 4 weeks
Rifampin and Isoniazid
Drug
3HR regimen of isoniazid and rifampicin once daily for three months

Treatment groups

3,520 Participants

are divided into 2 treatment groups

Group A: 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one monthExperimental treatment 1 intervention

Group B: 3HR regimen of isoniazid and rifampicin once daily for three monthsActive comparator 1 intervention

Trial outcomes

Primary outcomes

Number of participants with culture or GeneXpert MTB/RIF confirmed TB or clinically highly suggested TB

The primary aim is to estimate the effectiveness non-inferiority of 1H3P3 to 3HR.

Time frame