Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Jul 21, 2020

Keywords

ClinConnect Summary

The Hi-DoRi-3 trial is a study designed to test a new treatment for drug-sensitive pulmonary tuberculosis, which is a serious lung infection. The main goal is to see if using a higher dose of a medication called rifampicin for a shorter duration—specifically, for three months after the patient’s symptoms improve—can effectively treat tuberculosis safely. This study is currently not recruiting participants, but when it starts, it will include individuals aged between 18 and 65 who have tested positive for tuberculosis using a specific test called the Xpert MTB/RIF assay and have not been on tuberculosis treatment for more than seven days.

To participate, individuals must not have any known resistance to rifampicin, HIV, or certain chronic health issues like uncontrolled diabetes or liver disease. Those who qualify will receive the high-dose rifampicin treatment and will be monitored closely for its effectiveness and safety. This trial is important because it could lead to shorter treatment times for tuberculosis, which can make it easier for patients to complete their therapy and recover.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Documented positivity by sputum Xpert MTB/RIF assay
• • Administration of current tuberculosis therapy (if any) for no more than 7 days (≤7) at the time of enrolment.
• Exclusion Criteria:
• • Negative on Xpert MTB/RIF assay
• • Resistance to rifampicin as detected by an Xpert MTB/RIF assay
• • Known resistance to isoniazid, rifampicin, or pyrazinamide
• • HIV positive
• • Cancer patient on anti-cancer chemotherapy
• • Uncontrolled DM
• • Chronic hepatitis, liver cirrhosis
• • Any contraindications of drugs to be used