TB Notes 4, 2019 | Newsletters | Publications & Products | TB | CDC

TB Notes 4, 2019 | Newsletters | Publications & Products | TB | CDC

Research Initiatives to Improve TB Prevention and Control Efforts

The Clinical Research Branch (CRB) continues to work on several research initiatives to improve TB prevention and control efforts. Study descriptions and updates include the following:

• Study 31: This is the flagship project of DTBE, and the largest active TB treatment trial conducted by CDC to date. Over 2500 participants are enrolled at 34 clinical sites in 13 countries. The study aims to evaluate if high dose (1200 mg) daily rifapentine can shorten the necessary duration of treatment to 4 months, with or without moxifloxacin (rather than ethambutol). Study 31 has been conducted in partnership with NIH’s ACTG trials network, and expects to report results in late 2020. Current activities include completion of follow-up, database cleaning, collating data, preparing for primary data analysis, and designing a dissemination plan.
• Study 32: This is a phase two trial for active TB treatment aiming to optimize the dose of levofloxacin based on pharmacodynamic data. Currently, minimal inhibitory concentrations for all study isolates are being determined at CDC.
• Study 35: This is a pediatric study, for children ages 0-12. Recently there has been a global effort to scale-up use of pediatric preventive therapy, with a special emphasis on 3HP and related short-course rifapentine-based regimens. Study 35 is CDC’s first collaboration in the development of a novel TB drug formulation for young children and aims to assess the safety and pharmacokinetics of new water-dispersible formulations of isoniazid and rifapentine, allowing development of dosing guidelines for children of all ages. The study is being conducted entirely in South Africa. One site has begun enrolling, and two other sites will begin in early 2020.
• Study 37: This is a phase three treatment shortening regimen for LTBI. It compares six-weeks of daily rifapentine to the currently recommended 3-4-month rifamycin containing regimens and is currently enrolling.

Submitted by Carla Jeffries