Evaluating newly approved drugs for multidrug-resistant tuberculosis (endTB): study protocol for an adaptive, multi-country randomized controlled trial

L Guglielmetti, E Ardizzoni, M Atger, E Baudin… - Trials, 2021 - Springer
Background Treatment of multidrug-and rifampin-resistant tuberculosis (MDR/RR-TB) is
expensive, labour-intensive, and associated with substantial adverse events and poor …

The endTB observational study protocol: treatment of MDR-TB with bedaquiline or delamanid containing regimens

U Khan, H Huerga, AJ Khan, CD Mitnick… - BMC infectious …, 2019 - Springer
Background At a time when programs were struggling to design effective regimens for the
treatment of multidrug-resistant tuberculosis (MDR-TB), the marketing authorization of …

WHO recommendations on shorter treatment of multidrug-resistant tuberculosis

G Sotgiu, S Tiberi, L D'Ambrosio, R Centis, A Zumla… - The Lancet, 2016 - thelancet.com
Comment www. thelancet. com Vol 387 June 18, 2016 2487 and meropenem-sparing and
imipenem-sparing, regimens. The majority of the M tuberculosis strains that were isolated …

Treatment-shortening regimens for tuberculosis: updates and future priorities

F Saluzzo, VA Adepoju, R Duarte, C Lange… - Breathe, 2023 - Eur Respiratory Soc
In the past 2 years, remarkable advances have been made in shortening tuberculosis (TB)
treatment. In particular, four clinical trials (Study 31/A5349, Nix-TB, ZeNix and TB …

Nine-month, all-oral regimens for rifampin-resistant tuberculosis

L Guglielmetti, U Khan, GE Velasquez, M Gouillou… - MedRxiv, 2024 - medrxiv.org
Background After a history of poor treatments for rifampin-resistant tuberculosis (RR-TB),
recent advances have resulted in shorter, more effective treatments. However, they are not …

Standards for clinical trials for treating TB

P du Cros, J Greig, JWC Alffenaar… - … of Tuberculosis and …, 2023 - ingentaconnect.com
BACKGROUND: The value, speed of completion and robustness of the evidence generated
by TB treatment trials could be improved by implementing standards for best practice …

What is the best culture conversion prognostic marker for patients treated for multidrug-resistant tuberculosis?

M Bastard, E Sanchez-Padilla… - … of Tuberculosis and …, 2019 - ingentaconnect.com
INTRODUCTION: Identification of good prognostic marker for tuberculosis (TB) treatment
response is a necessary step on the path towards a surrogate marker to reduce TB trial …

Bayesian uncertainty directed trial designs

S Ventz, M Cellamare, S Bacallado… - Journal of the American …, 2019 - Taylor & Francis
Most Bayesian response-adaptive designs unbalance randomization rates toward the most
promising arms with the goal of increasing the number of positive treatment outcomes during …

The STREAM trial: missed opportunities and lessons for future clinical trials

M Loveday, A Reuter, J Furin, JA Seddon… - The Lancet Infectious …, 2019 - thelancet.com
Final results of the STREAM trial were presented at the 2018, 49th UnionWorld Conference
on Lung Health, held in The Hague, The Netherlands. STREAM is a randomised controlled …

A comparison of clinical development pathways to advance tuberculosis regimen development

V Chang, PPJ Phillips, MZ Imperial, P Nahid… - BMC infectious …, 2022 - Springer
Background Current tuberculosis (TB) regimen development pathways are slow and in
urgent need of innovation. We investigated novel phase IIc and seamless phase II/III trials …