Rifampicin at High Dose for Difficult-to-Treat Tuberculosis

Phase 2

• Conditions: Tuberculosis
• Interventions: Drug: Rifampin

• Registration Number: NCT04768231
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief 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.

Detailed 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 Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-22
• Last Update Submitted: 2021-02-22
• Study First Posted: 2021-02-24
• Last Update Posted: 2021-02-24
• Study Start: 2021-04-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
R35HZE	Rifampin	Participants treated with rifampicin at a dose of 35 mg per kilogram of body weight per day, added to the standard doses of isoniazid, pyrazinamide and ethambutol.

Primary Outcome Measures

Name	Time	Method
Safety of rifampicin at 35mg/kg/day	During the first 8 weeks after treatment start	Rate of grade 3 or higher adverse events as compared to that in historical controls

Secondary Outcome Measures

Name	Time	Method
Efficacy of rifampicin at 35mg/kg/day in pulmonary tuberculosis	At week 8 after treatment start	Rate of sputum liquid culture conversion (only pulmonary TB participants)
Tolerability of rifampicin at 35mg/kg/day	During the first 8 weeks after treatment start	Rate of adverse events of any grade as compared to that in historical controls

Trial Locations

Locations (5)

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona; 🇪🇸 Barcelona, Spain

University Medical Center; 🇳🇱 Groningen, Netherlands

Instituto Nacional de Enfermedades Respiratorias y del Ambiente; 🇵🇾 Asunción, Paraguay

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands

Centro Hospitalario Universitario de Sao Joao; 🇵🇹 Porto, Portugal