Introduction: Tuberculosis (TB) infection is a key driver of the TB pandemic, with over 10.6 million people fell ill with TB disease in 2022. About one-quarter of the global population is estimated to be infected with TB bacteria. Around 5-10% of people with TB infection will develop active and contagious TB disease, which could be largely avoided if TB infection is identified and given effective preventative treatment, before progression to active disease. The long treatment of TB infection with regimens lasting from three to nine months is a significant barrier to treatment completion in individuals with a confirmed diagnosis of TB infection. Adapting a shorter regimen than the current regimens could lead to a higher treatment completion rate and increased uptake of preventative therapy for TB, as well as reduced side effects.
Methods and analysis: An open-label, randomized clinical trial (1:1) will be performed in two study sites in Ha Noi, Vietnam (Vietnam National Lung Hospital and Ha Noi Lung Hospital). Adult household contacts (n=350) of people with new, bacteriologically-confirmed, pulmonary, drug-susceptible TB who initiate treatment will be invited to participate.
Aim: To compare the TB preventive therapy completion rates and adverse event incidence between a new one-month regimen (1HP) versus the current three-month regimen (3HR)\*.
\*1HP= one month of daily isoniazid (H/INH) and rifapentine (P/RPT) 3HR= three months of daily isoniazid (H/INH) and rifampicin (R/RIF)
Household contacts of people with new, bacteriologically-confirmed, pulmonary, drug-susceptible TB who initiated treatment with residence in the intervention areas;
Positive QFT-Plus or TST results (TST induration of at least 5mm)
Agree to remain in contact and provide updated information as necessary, and have no current plans to relocate outside the designed area for the duration of the study;
Age ≥ 18 years;
Indeterminate results on QFT-Plus;
Clinical or radiographic suspicions or history of previous active TB;
Known hypersensitivity or contraindication to any components of the regimens;
Weight <30kg;
Parallel
Isoniazid
DrugThis randomized control trial will compare the treatment adherence and safety of the 1HP (Arm B) regimen and standard 3HR (Arm A) regimens for TB infection treatment
Rifapentine
DrugThis randomized control trial will compare the treatment adherence and safety of the 1HP (Arm B) regimen and standard 3HR (Arm A) regimens for TB infection treatment
Rifampicin
DrugThis randomized control trial will compare the treatment adherence and safety of the 1HP (Arm B) regimen and standard 3HR (Arm A) regimens for TB infection treatment
1. % Adequate adherence in each arm
Adequate treatment adherence is defined as taking ≥90% of TB preventive therapy doses within the time frame. Treatment adherence will be recorded by both study schedule and programmatic adherence.
The incidence rate of severe adverse events among two arms.
Severe adverse events are defined (DAIDS) as any untoward medical occurrence that, at any dose: * Results in death * Life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent disability/incapacity * Congenital anomaly/birth defect
Comparison of adherence measured as the proportion of treatment taken in the regimens (1HP vs 3HR).
The incidence rate of a targeted event of grade 3,4 or 5*** and one grade increase from the baseline among two arms.
Targeted event includes: 1. Flu-like symptoms including weakness, fatigue, nausea, vomiting, headache, fever, aches, sweats, dizziness, shortness of breath, flushing, or chills. 2. Hepatotoxicity, defined as a five-fold or greater increase in the AST/ALT level, a three-fold or greater increase with clinical symptoms, or total bilirubin level \> 51.3 micromole/L. 3. Peripheral neuropathy (Clinical diagnosis)
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