Dear Colleague Letters
Tuberculosis Trials Consortium launches new TB clinical trial
November 27, 2023
Dear Colleagues,
CDC’s Tuberculosis Trials Consortium (TBTC) launched an international clinical trial, Combination Regimens for Shortening Tuberculosis Treatment, or CRUSH-TB. This exciting new trial aims to identify new combinations of drugs to provide additional options to shorten the treatment of tuberculosis (TB) disease. These new regimens may improve drug tolerability and minimize drug interactions, giving healthcare providers more options to treat TB disease and completion of treatment. The trial compares the effectiveness and safety of new 4-month bedaquiline, moxifloxacin, and pyrazinamide-based regimens to the standard of care 6-month regimen among patients with drug-susceptible pulmonary TB disease.
CRUSH-TB aims to enroll at least 288 participants from international TBTC sites over the next year. The study will randomly assign participants into one of three different study groups. The participants will know which TB treatment regimen they receive. The adaptive study design allows the researchers to add study groups to the trial to assess new TB treatment regimens. The trial will include a diverse group of participants including, children 12 years of age or older and people with human immunodeficiency virus (HIV).
CDC’s cutting-edge research uses domestic experiences to strengthen global TB elimination efforts and inform new treatment guidelines and recommendations. For this clinical trial, TBTC builds on the success of an international phase 3 clinical trial conducted with the National Institutes of Health-sponsored AIDS Clinical Trials Group. The results from that trial informed interim guidance for a 4-month treatment regimen to treat drug-susceptible pulmonary TB disease.
Shorter treatment regimens for TB disease can be more convenient and help patients finish treatment faster. I would like to thank the researchers, clinical staff, and future clinical trial participants for their contributions to bring us closer to our goal of TB elimination.
Sincerely,
Wendy Carr, PhD
Clinical Research Branch Chief
Division of Tuberculosis Elimination
National Center for HIV, Viral Hepatitis, STD, and TB Prevention