1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam

Launched by FREUNDESKREIS FÜR INTERNATIONALE TUBERKULOSEHILFE E.V · Dec 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment plans for preventing tuberculosis (TB) infection in people who live with someone diagnosed with active TB. Researchers want to see if a new one-month treatment (called 1HP) is as effective as the current three-month treatment (called 3HR) when it comes to helping people complete their therapy and keeping them safe from side effects. The trial will involve about 350 adults living in Hanoi, Vietnam, who have been in close contact with someone diagnosed with drug-susceptible TB.

To be eligible for the study, participants must be at least 18 years old and live with someone who has a confirmed case of TB. They should also have tested positive for TB infection through specific tests. Participants will be asked to attend study visits and keep in touch with the researchers during the trial. Importantly, individuals with certain health conditions, like liver problems or a history of active TB, won't be able to join. This trial is not yet recruiting participants, but it aims to help improve how we prevent TB infections in the future.

Gender

ALL

Eligibility criteria

• 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).