ACTG A5409 (RAD-TB): Study protocol for a phase 2 randomized, adaptive, dose-ranging, open-label trial of novel regimens for the treatment of pulmonary tuberculosis

ACTG A5409 (RAD-TB): Study protocol for a phase 2 randomized, adaptive, dose-ranging, open-label trial of novel regimens for the treatment of pulmonary tuberculosis

Abstract Background The standard of care (SOC) treatment for drug-susceptible pulmonary tuberculosis (DS-TB) consists of isoniazid, rifampicin, pyrazinamide, and ethambutol (HRZE). New treatment regimen options for DS-TB are needed as HRZE is long in duration (6 months), associated with frequent adv...

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Main Authors: Linda J. Harrison, Gustavo E. Velásquez, Russell R. Kempker, Marjorie Z. Imperial, Eric Nuermberger, Susan E. Dorman, Elisa Ignatius, Janeway Granche, Patrick P. J. Phillips, Jennifer Furin, Eunsol Yang, Colleen Foley, Shawn Chiambah, Rochelle Rogers, Austin Van Grack, Jhoanna Roa, Justin Shenje, Sandy Nerette, Cecilia Kanyama, Rachel Bakyayita Kyeyune, Alberto Mendoza-Ticona, William Murtaugh, Salah Foraida, Melanie Goth, Andrew Vernon, Kelly E. Dooley, Radojka M. Savic
Format: Article
Language:English
Published: BMC 2025-08-01
Series:Trials
Subjects:
Tuberculosis
Drug-susceptible
Platform trial
Bedaquiline
Pretomanid
Linezolid
Online Access:https://doi.org/10.1186/s13063-025-08973-w
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https://doi.org/10.1186/s13063-025-08973-w

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