Novel Triple-dose Tuberculosis Retreatment Regimen

Launched by INSTITUTE OF TROPICAL MEDICINE, BELGIUM · Feb 5, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new high-dose treatment for patients who have had recurring pulmonary tuberculosis (TB) that is still sensitive to rifampicin, a common TB medication. The goal is to see if this new high-dose treatment is just as safe as the standard dose, while helping patients recover from their illness. The researchers want to ensure that this new approach can effectively support patients dealing with multidrug-resistant TB.

To join the trial, participants must be newly registered patients with smear-positive recurrent pulmonary TB, which means they have a confirmed diagnosis of TB that can be seen under a microscope. Both adults and children can take part, as long as they can provide consent and live close to a health facility with a doctor. However, some individuals may not qualify, including those with initial drug-resistant TB, pregnant or breastfeeding women, and individuals with certain liver conditions. Participants can expect to receive close monitoring and care throughout the study as researchers gather important data on the treatment's safety and effectiveness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All newly registered patients with smear-positive recurrent pulmonary TB
• • Adults as well as children (no age limit)
• • Able and willing to provide written informed consent
• • Added for stage 2: lives within 5 km of a health facility with a medical doctor
• Exclusion Criteria:
• • All patients with TB initially resistant to rifampicin on Xpert MTB/RIF testing
• • Patients transferred to a health facility not supported by the Damien Foundation
• • Patients previously enrolled in the trial, and with another episode of rifampicin-susceptible TB during the study period
• • Those with grade III elevation of liver function tests at baseline, or with clinically active liver disease at screening
• • Pregnant or breastfeeding woman
• • HIV co-infected patients requiring treatment with a protease inhibitor