An Open-label, Randomized Controlled Trial of the New One-month Regimen Versus the Current Three-month Regimen for the Treatment of Tuberculosis Infection in Vietnam

TBIshort

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)

2024-04-01

2024-12-01

2026-12-01

Not yet recruiting

Early phase I

350

Inclusion Criteria: * 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; * Capable of providing signed informed consent; * Willing to participate in the study visits and procedures Exclusion Criteria: * 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; * Acute or chronic liver failure with elevated liver enzymes or evidence of liver dysfunction such as jaundice or a history of liver failure caused by isoniazid or rifampicin; History of liver cirrhosis at any time before study entry; * Infection with suspected or confirmed tuberculosis strains resistant to isoniazid or rifampicin; * Porphyria- Porphyrin metabolism disorder; * Polyneuropathy (self-reported/ confirmed); * Pregnant or planning to become pregnant within 120 days of enrollment; * Any other severe underlying condition that would, in the opinion of the investigator, compromise the patient's safety or outcome in the trial; * Participation in other clinical intervention trials or research protocols (participation in other studies that do not involve an intervention may be allowed, but this must be discussed and approved by the Chief Investigator).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Households will be randomized in a 1:1 ratio to the two treatment groups (1HP/3HR) using cluster randomization', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 350, 'type': 'ESTIMATED'}}

2024-02-20