Status:
NOT_YET_RECRUITING
1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam
Lead Sponsor:
Freundeskreis Für Internationale Tuberkulosehilfe e.V
Conditions:
Tuberculosis Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Latent TB infection, hereafter referred to as TB infection, is a key driver of the TB pandemic. Over 10.6 million people developed active TB in 2022 and about one-quarter of the global population is e...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06191692
Start Date
August 1 2025
End Date
December 1 2027
Last Update
March 19 2025
Active Locations (2)
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1
Vietnam National Lung Hospital
Hanoi, Hanoi, Vietnam, 10000
2
Ha Noi Lung Hospital
Hà Nội, Vietnam, 10000