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Rifampicin at High Dose for Difficult-to-Treat Tuberculosis — RIAlta  

Tuberculosis Clinical Trial

Official title:
Safety of Rifampicin at High Dose for the Treatment of Adult Subjects With Complex Drug Susceptible Pulmonary and Extrapulmonary Tuberculosis

Clinical Trial Summary

The purpose of this study is to assess the safety of rifampicin given at a dose three times as the standard one, in persons with tuberculosis that belong to groups that have not been widely included in previous trials.

Clinical Trial Description

A prospective, one-arm, open-label trial to evaluate the safety of rifampicin at 35mg/kg per day, added to the remaining standard first-line drugs, in subjects with tuberculosis belonging to groups that have been underrepresented in previous trials: persons living with HIV, older than 65 years, malnourished, diabetics, and chronic stable liver disease. The main outcome is the rate of severe adverse events and adverse events leading to treatment modification as compared to that in a historical cohort (patietns belonging to these groups treated in the same centers from 2017-2019). Microbiological efficacy and extended follow-up data until one year after treatment will also be collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04768231
Study type Interventional
Source Hospital Universitari Vall d'Hebron Research Institute
Contact Adrián Sánchez-Montalvá, PhD
Phone +34 934893000
Email adrian.sanchez.montalva@gmail.com
Status Not yet recruiting
Phase Phase 2
Start date April 1, 2021
Completion date December 31, 2023
View Details
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