Clinical Trials Logo

Clinical Trial Summary

TB PRACTECAL is a multi-centre, open label, multi-arm, randomised, controlled, phase II-III trial; evaluating short treatment regimens containing bedaquiline and pretomanid in combination with existing and re-purposed anti-TB drugs for the treatment of biologically confirmed pulmonary multi drug-resistant TB (MDR-TB).


Clinical Trial Description

This is a multi-centre, open label, multi-arm, randomised, controlled, phase II-III trial; evaluating short treatment regimens containing bedaquiline and pretomanid in combination with existing and re-purposed anti-TB drugs for the treatment of biologically confirmed pulmonary multidrug-resistant TB (MDR-TB). The study will be divided into two stages, with a seamless transition between the stages, meaning recruitment into an arm will only stop after a decision has been taken following stage 1 primary end point data analysis. All recruited patients will be followed up to 108 weeks post randomisation unless they die or withdraw consent. The local standard of care (SOC) MDR-TB regimen will be used as the internal control for both safety and efficacy. The first stage corresponds to a Phase II trial of safety and preliminary efficacy in patients with MDR-TB. Patients will be recruited into 3 parallel B and Pa containing regimen arms plus a SOC control. The main objective of Stage 1 is to select drug regimens for evaluation in Stage 2 based on 8 week safety and efficacy endpoints. All stage 1 patients will be hospitalised for 8 weeks for intensive cardiological evaluations to establish the QT-specific liability of the regimens. Investigational arms that do not meet predefined safety and efficacy criteria (percentage culture conversion >40%; percentage discontinuation and death <45%) will not be considered for further evaluation. The regimens that do not meet these pre-defined safety and/or efficacy criteria will be eligible to be evaluated for long term safety, tolerability and efficacy in Stage 2. If less than two investigational arms are available for stage two assessment, the SAC will make recommendations on whether new arms should be introduced in the study. If more than two arms are available for the Stage 2 assessment, two regimens will be chosen. The SAC will make recommendations on which arms to take forward to the trial steering committee. The second stage corresponds to a phase III trial. Patients in this stage will be recruited into the arms chosen from stage 1 plus the SOC. The regimens will primarily be evaluated for safety and efficacy in comparison with the SOC arm at 72 weeks post randomisation. The primary efficacy outcome will be a composite endpoint of the percentage of unfavourable outcomes. The secondary outcomes will include safety outcomes and in particular the percentage of Grade 3 or 4 AEs and SAEs in the investigational regimens compared with the SOC. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02589782
Study type Interventional
Source Medecins Sans Frontieres, Netherlands
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date January 2017
Completion date December 2022

See also
  Status Clinical Trial Phase
Recruiting NCT06084715 - The INSTITUT Study
Terminated NCT03028129 - Prevention of Tuberculosis in Prisons Phase 4
Not yet recruiting NCT06253715 - Shortened Regimen for Drug-susceptible TB in Children Phase 3
Withdrawn NCT03862248 - Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More Phase 3
Completed NCT03271567 - Nanodisk-MS Assay for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients
Completed NCT03199313 - Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid Phase 1
Recruiting NCT04919239 - Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB) Phase 2
Active, not recruiting NCT03251196 - TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
Recruiting NCT05926466 - BTZ-043 Dose Evaluation in Combination and Selection Phase 2
Recruiting NCT04752592 - Evaluation of a Rapid Point-of-Care Serological Triage Test for Active TB N/A
Completed NCT04874948 - Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment Phase 1
Not yet recruiting NCT04968886 - TuBerculosis Viability Interregional Study and Agreement on Biological Tests
Not yet recruiting NCT04485156 - Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3) Phase 3
Active, not recruiting NCT02715271 - Study of TB Lesions Obtained in Therapeutical Surgery
Completed NCT01364324 - Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
Active, not recruiting NCT04179500 - A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis Volunteers Phase 2
Completed NCT05899400 - A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides
Recruiting NCT04938596 - Airborne Preventive Measures to Reduce New TB Infections in Household Contacts N/A
Recruiting NCT05455112 - Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis Phase 2
Completed NCT03044158 - GeneXpert Performance Evaluation for Linkage to Tuberculosis Care N/A