Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB

Summary

The UNITE4TB consortium is a group of universities and pharmaceutical companies funded by the European Union. This consortium are carrying out a trial to find better and faster ways to treat tuberculosis (TB). The standard treatment for TB takes 24 weeks and uses four drugs. The consortium want to find new treatments that are faster but just as safe and effective.

In the trial, two new drugs will be used, BTZ-043 and GSK3036656, along with the drugs that are already used to treat TB in a variety of combinations (11 different combinations initially). These new drugs have worked well in tests with animals and have reduced the amount of TB bacteria in people's sputum/phlegm when used alone for two weeks. These new drugs will be used in combination with other TB drugs for a longer time (up to 16 weeks) in people with TB. The UNITE4TB consortium want to see if they work well and are safe.

This trial will take place at sites across the world and will involve people with TB of the lungs that would usually respond well to the standard treatment. But the new treatments being tested might also work for people with drug resistant TB, that's harder to treat.

The trial has two parts. In the first part, different combinations of drugs will be tried on up to 700 people for 16 weeks. These combinations will be compared to the standard 24-week treatment to see which ones work the best and are safe.

In the second part, the best combinations from the first part will be taken to try to find out what the best length of time is to give the treatment for. These combinations will be tried on up to 1800 people giving them either 8, 10, 12, 14 or 16 weeks treatment. The investigators will follow these people for a total of 72 weeks to make sure the treatment is working.

The UNITE4TB consortium hope that this trial will find new treatments that are fast, safe, and effective for both regular TB and resistant TB. If it works, it can then be tested again in a bigger trial to be sure.

Conditions

• Pulmonary Tuberculosis

Interventions

DRUG

Ganfeborole

Oral daily dosage of 20mg.

DRUG

BTZ-043

Oral daily dosage of 1000mg.

DRUG

Bedaquiline (B)

Oral daily dosage of 400mg for the first 2 weeks, thereafter 100mg daily until end of treatment.

DRUG

Delamanid (D)

Oral daily dosage of 300mg.

DRUG

Pretomanid (Pa)

Oral daily dosage of 200mg.

DRUG

Moxifloxacin (M)

Oral daily dosage of 400mg.

DRUG

Linezolid (L)

Oral daily dosage of 600mg for the first 8 weeks.

DRUG

Pyrazinamide (Z)

Oral daily dosage of 1200mg-2000mg depending on weight.

DRUG

Rifampicin (R)

Oral daily dosage of 450mg-750mg depending on weight.

DRUG

Isoniazid (H)

Oral daily dosage of 225mg-375mg depending on weight.

DRUG

Ethambutol (E)

Oral daily dosage of 825mg-1375mg depending on weight.

DRUG

Delpazolid (DZD)

Oral daily dosage of 1200mg

DRUG

Quabodepistat (Q)

Oral daily dosage of 30mg

Sponsors & Collaborators

• Radboud University Medical Center

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• Research Center Borstel

  collaborator OTHER

• Lygature

  collaborator UNKNOWN

• TASK Applied Science

  collaborator OTHER

• Vita-Salute San Raffaele University

  collaborator UNKNOWN

• Helmholtz Zentrum Munchen

  collaborator UNKNOWN

• KNCV Tuberculosis Foundation

  collaborator OTHER

• Critical Path Institute

  collaborator UNKNOWN

• European Lung Foundation

  collaborator UNKNOWN

• Instituto de Saude Publica da Universidade do Porto

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• Institut de Recherche pour le Developpement

  collaborator OTHER_GOV

• University of Hamburg-Eppendorf

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• TB Alliance

  collaborator UNKNOWN

• Find

  collaborator OTHER

• University of Milano

  collaborator UNKNOWN

• University of St Andrews

  collaborator OTHER

• Uppsala University

  collaborator OTHER

• European Respiratory Society

  collaborator OTHER

• Tuberculosis Network European Trialsgroup

  collaborator NETWORK

• Janssen, LP

  collaborator INDUSTRY

• Otsuka Pharmaceutical Development & Commercialization, Inc.

  collaborator INDUSTRY

• German Center for Infection Research

  collaborator OTHER

• LMU University Hospital Munich

  collaborator UNKNOWN

• University of Cambridge

  collaborator OTHER

• GlaxoSmithKline

  collaborator INDUSTRY

• University College, London

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-09

Primary Completion

2027-02-24

Completion

2027-08-11

Countries

• Moldova
• South Africa
• Tanzania
• Uganda
• Vietnam

Study Locations