ACADEMIA AND INDUSTRY UNITED INNOVATION AND TREATMENT FOR TUBERCULOSIS

Información del proyecto

UNITE4TB

Identificador del acuerdo de subvención: 101007873

DOI

10.3030/101007873

Fecha de la firma de la CE 29 Junio 2021

Fecha de inicio 1 Junio 2021

Fecha de finalización 31 Mayo 2028

Financiado con arreglo a

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coste total

€ 185 000 000,00

Aportación de la UE

€ 92 500 000,00

Coordinado por

STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM
Netherlands

CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.

Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .

Resultado final

Documents, reports (18)

Report of kick-off meeting
Annual report on status of posting results for phase 2A (2)
Annual report on status of posting results for phase 2B/C (2)
Midterm recruitment report for phase 2B/C

Midterm recruitment report for phase 2B/CNote: this is a summary report for all phase 2B/C studies to be performed

Target product profile for stage-specific biomarkers - submitted to WHO and EMA

Target product profile for stage-specific biomarkers – submitted to WHO and EMA

Report of third annual consortium meeting
Communication and dissemination plan
Report of second annual consortium meeting
Annual report on status of posting results for phase 2B/C (1)
Establish CAG
Establish SAB and RAB
Annual report on status of posting results for phase 2A (1)
Midterm recruitment report for phase 2A (1)
DAT training module developed
Attendance at key regional stakeholder events to discuss findings (1)
Report of first annual consortium meeting
Establish EAB
Code for pharmacodynamic models applicable phase 2A and 2B/C data (1)

Code for pharmacodynamic models applicable phase 2A and 2B/C data (1)

Websites, patent fillings, videos etc. (2)

Dissemination of educational materials through CME-webinars (1)
Visual identity and communication toolkit, including project website

Other (3)

Inaugural meeting with communication professionals of the partners in the consortium
Establish Young Investigators Group
Seminars for healthcare workers (1)

Publicaciones

Peer reviewed articles (30)

Machine Learning and Pharmacometrics for Prediction of Pharmacokinetic Data: Differences, Similarities and Challenges Illustrated with Rifampicin

Autores: Keutzer L, You H, Farnoud A, Nyberg J, Wicha SG, Maher-Edwards G, Vlasakakis G, Moghaddam GK, Svensson EM, Menden MP, Simonsson USH, On Behalf Of The UNITE4TB Consortium
Publicado en: Pharmaceutics, 2022, ISSN 1999-4923
Editor: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics14081530

Improving Genotype Imputation in High‐Dimensional Pharmacogenomics Using Multiple Imputation: Evaluation with Machine Learning Approaches

Autores: Innocent G. Asiimwe, Tao You, Daniel F. Carr, Munir Pirmohamed, Geraint Davies, Andrea L. Jorgensen, null null
Publicado en: Clinical Pharmacology & Therapeutics, Edición 119, 2026, Página(s) 964-978, ISSN 0009-9236
Editor: Nature Publishing Group
DOI: 10.1002/cpt.70171

A flexible multi‐metric Bayesian framework for decision‐making in Phase II multi‐arm multi‐stage studies

Autores: Suzanne M. Dufault; Angela M. Crook; Katie Rolfe; Patrick P. J. Phillips
Publicado en: Statistics in Medicine , 43 (3) pp. 501-513. (2024), Edición 17, 2024, Página(s) 501-513, ISSN 0277-6715
Editor: John Wiley & Sons Inc.
DOI: 10.1002/sim.9961

Management of adverse events in TB care and active TB drug safety monitoring

Autores: Shamsuddeen Yusuf Ma'aruf, Aparna Sharma, Shannon Fox, Raquel Duarte, Christoph Lange, Simon Tiberi
Publicado en: Breathe, Edición 22, 2026, Página(s) 250203, ISSN 1810-6838
Editor: European Respiratory Society
DOI: 10.1183/20734735.0203-2025

Treatment-shortening regimens for tuberculosis: updates and future priorities

Autores: Francesca Saluzzo, Victor Abiola Adepoju, Raquel Duarte, Christoph Lange, Patrick P.J. Phillips
Publicado en: Breathe, Edición 19 (3), October, 2023, ISSN 1810-6838
Editor: European Respiratory Society
DOI: 10.1183/20734735.0028-2023

The role of the UNITE4TB Young Investigators Group in empowering early career researchers through mentorship, capacity building, and innovation

Autores: A. Vasiliu, F. Saluzzo, J.A. Schildkraut, R. Villar-Hernandez, J.P. Ramos, M. Vieira, G. Thwaites, D.M. Cirillo, C. Lange, R. Duarte
Publicado en: IJTLD Open, Edición 3, 2026, Página(s) 105-107, ISSN 3005-7590
Editor: International Union Against Tuberculosis and Lung Disease
DOI: 10.5588/ijtldopen.25.0651

Addressing challenges along the ‘access cascade’ for new TB regimens

Autores: J. Servello, P. de Colombani, L. Dall’Olio, G. Gargioni, M.C.B. Raviglione
Publicado en: IJTLD Open, Edición 3, 2026, Página(s) 122-137, ISSN 3005-7590
Editor: International Union Against Tuberculosis and Lung Disease
DOI: 10.5588/ijtldopen.25.0610

Low-level BTZ-043 resistance in <i>Mycobacterium tuberculosis</i> and cross-resistance to bedaquiline and clofazimine

Autores: A. Ghodousi, I. Iannucci, F. Saluzzo, J. Dreisbach, S. Mirold-Mei, M. Hoelscher, D.M. Cirillo
Publicado en: IJTLD OPEN, Edición 2, 2025, Página(s) 604-609, ISSN 3005-7590
Editor: International Union Against Tuberculosis and Lung Disease
DOI: 10.5588/ijtldopen.25.0301

Candidate anti-tuberculosis medicines and regimens under clinical evaluation

Autores: Michael Hoelscher, David Barros-Aguirre, Masoud Dara, Norbert Heinrich, Eugene Sun, Christoph Lange, Simon Tiberi, Charles Wells
Publicado en: Clinical Microbiology and Infection, Edición 30, 2024, Página(s) 1131-1138, ISSN 1198-743X
Editor: Blackwell Publishing Inc.
DOI: 10.1016/j.cmi.2024.06.016

An Interactive Pharmacokinetic‐Pharmacodynamic Framework to Evaluate Bedaquiline Dose Modifications in Adults With Tuberculosis

Autores: Yu‐Jou Lin, Frances Okibedi, Mats O. Karlsson, Elin M. Svensson
Publicado en: CPT: Pharmacometrics &amp; Systems Pharmacology, Edición 15, 2026, Página(s) e70264, ISSN 2163-8306
Editor: Nature Publishing Group
DOI: 10.1002/psp4.70264

Tuberculosis: current challenges and beyond

Autores: Raquel Villar-Hernández, Arash Ghodousi, Olha Konstantynovska, Raquel Duarte, Christoph Lange, Mario Raviglione on behalf of the UNITE4TB Consortium
Publicado en: Breath, 2023, ISSN 2073-4735
Editor: European Respiratory Society
DOI: 10.1183/20734735.0166-2022

Towards model-informed precision dosing of clofazimine, moxifloxacin, and terizidone/cycloserine in the treatment of drug-resistant tuberculosis: An external model evaluation study

Autores: Emily Behrens, Niklas Köhler, Max Münchow, Nika Zielinski, Christoph Pfaffendorf, Hans-Peter Grobbel, Dagmar Schaub, Maja Reimann, Patricia Maria Sánchez Carballo, Barbara Kalsdorf, Doris Hillemann, Martin Kuhns, Sabine Hofmann-Thiel, Harald Hoffmann, Laurent A. Decosterd, Eva Choong, Rob Aarnoutse, Christoph Lange, Sebastian G. Wicha
Publicado en: Tuberculosis, Edición 157, 2026, Página(s) 102744, ISSN 1472-9792
Editor: Churchill Livingstone
DOI: 10.1016/j.tube.2026.102744

Towards comprehensive clinical trials for new tuberculosis drug regimens: policy recommendations from a stakeholder analysis

Autores: Simone Villa, Pierpaolo de Colombani, Lucia Dall’Olio, Giuliano Gargioni, Mario Raviglione
Publicado en: BMJ Global Health, Edición 2024;9: e014630, 2024, Página(s) 1-9, ISSN 2059-7908
Editor: BMJ Journals
DOI: 10.1136/bmjgh-2023-014630

Tuberculosis Treatment Monitoring and Outcome Measures: New Interest and New Strategies

Autores: Heyckendorf J, Georghiou SB, Frahm N, Heinrich N, Kontsevaya I, Reimann M, Holtzman D, Imperial M, Cirillo DM, Gillespie SH, Ruhwald M, Consortium UNITE4TB
Publicado en: Clinical Microbiology Reviews, Edición 21 March 2022, 2022, Página(s) n/a, ISSN 1098-6618
Editor: American Society for Microbiology
DOI: 10.1128/cmr.00227-21

Extension and application of the partial continual reassessment method to a Phase-IIa dose-finding Tuberculosis trial with a continuous endpoint

Autores: Alessandra Serra, Thomas Jaki, Pavel Mozgunov
Publicado en: Statistics in Biopharmaceutical Research, 2026, Página(s) 1-23, ISSN 1946-6315
Editor: Informa UK Limited
DOI: 10.1080/19466315.2026.2676642

Developing biomarker assays to accelerate tuberculosis drug development: defining target product profiles 

Autores: Stephen H Gillespie , Andrew R DiNardo, Sophia B Georghiou, Wilber Sabiiti , Mikashmi Kohli, Ursula Panzner , Irina Kontsevaya6, Norbert Hittel, Lieven J Stuyver, Jia Bin Tan, Reinout van Crevel, Christoph Lange, Thuong Nguyen Thuy Thuong, Jan Heyckendorf, Morten Ruhwald, Norbert Heinrich
Publicado en: Lancet Microbe, 2024, Página(s) 1-11, ISSN 2666-5247
Editor: Elsevier ltd.
DOI: 10.1016/s2666-5247(24)00085-5

An evaluation of designs for Phase I/IIa dose-finding studies in Tuberculosis

Autores: Alessandra Serra, Pavel Mozgunov, Patrick PJ Phillips, Thomas Jaki
Publicado en: Statistical Methods in Medical Research, 2026, ISSN 0962-2802
Editor: SAGE Publications
DOI: 10.1177/09622802261430905

Advances in tuberculosis biomarkers: unravelling risk factors, active disease and treatment success

Autores: Jodie A. Schildkraut, Niklas Köhler, Christoph Lange, Raquel Duarte, Stephen H. Gillespie
Publicado en: Breathe, Edición 20, 2024, Página(s) 240003, ISSN 1810-6838
Editor: European Respiratory Society
DOI: 10.1183/20734735.0003-2024

The importance of getting the dose right in the treatment of tuberculosis

Autores: Andrii Dudnyk, Wandini Lutchmun, Raquel Duarte, Christoph Lange, Elin M. Svensson
Publicado en: Breathe, Edición 21, 2025, Página(s) 240177, ISSN 1810-6838
Editor: European Respiratory Society
DOI: 10.1183/20734735.0177-2024

Enhancing tuberculosis care in lower and middle-income countries through digital adherence technologies

Autores: Rabbyia Ahmad, João Pedro Ramos, Raquel Duarte, Christoph Lange, Job Van Rest
Publicado en: Breathe, Edición 22, 2026, Página(s) 250173, ISSN 1810-6838
Editor: European Respiratory Society
DOI: 10.1183/20734735.0173-2025

Rising bedaquiline resistance: exploring potential causes and next steps

Autores: Jodie A. Schildkraut, Debra Flood, Derek J. Sloan, Norbert Heinrich, Shannon Fox, Christoph Lange, Charles Wells, Simon Tiberi
Publicado en: European Respiratory Journal, Edición 67, 2026, Página(s) 2501531, ISSN 0903-1936
Editor: European Respiratory Society
DOI: 10.1183/13993003.01531-2025

Model‐Informed Once‐Daily Dosing Strategy for Bedaquiline and Delamanid in Children, Adolescents and Adults with Tuberculosis

Autores: Yu‐Jou Lin, Louvina E. van der Laan, Mats O. Karlsson, Anthony J. Garcia‐Prats, Anneke C. Hesseling, Elin M. Svensson
Publicado en: Clinical Pharmacology &amp; Therapeutics, Edición 117, 2025, Página(s) 1292-1302, ISSN 0009-9236
Editor: Nature Publishing Group
DOI: 10.1002/cpt.3536

Interoccasion variability in population pharmacokinetic models: identifiability, influence, interdependencies and derived study design recommendations

Autores: Emily Behrens, Sebastian G. Wicha
Publicado en: Journal of Pharmacokinetics and Pharmacodynamics, Edición 52, 2025, ISSN 1567-567X
Editor: Kluwer Academic/Plenum Publishers
DOI: 10.1007/s10928-025-09966-7

Designing a response-over-continuous-intervention (ROCI) randomised trial: Implementation in the Phase 2C part (duration ranging) of the PARADIGM4TB trial

Autores: Tra My Pham, Angela M. Crook, Katie Rolfe, Patrick P.J. Phillips, Suzanne M. Dufault, Matteo Quartagno
Publicado en: Contemporary Clinical Trials, Edición 155, 2026, Página(s) 108002, ISSN 1551-7144
Editor: Elsevier BV
DOI: 10.1016/j.cct.2025.108002

The AMR Accelerator: from individual organizations to efficient antibiotic development partnerships

Autores: Josepine Fernow, Marie Olliver, William Couet, Sophie Lagrange, Meindert H. Lamers, Ole F. Olesen, Kristina Orrling, Michel Pieren, Derek J. Sloan, Juan José Vaquero, Timothy J. Miles, Anders Karlén
Publicado en: Nature Reviews Drug Discovery, Edición 24, 2025, Página(s) 1-2, ISSN 1474-1776
Editor: Nature Publishing Group
DOI: 10.1038/d41573-024-00138-9

Enhancing collaboration between national TB programmes and researchers

Autores: L. Dall’Olio, P. de Colombani, J. Servello, G. Gargioni, R. Duarte, M. Raviglione
Publicado en: IJTLD Open, Edición 3, 2026, Página(s) 111-113, ISSN 3005-7590
Editor: International Union Against Tuberculosis and Lung Disease
DOI: 10.5588/ijtldopen.25.0624

Implementing molecular tuberculosis diagnostic methods in limited-resource and high-burden countries

Autores: Anca Vasiliu, Antonia Morita Iswari Saktiawati, Raquel Duarte, Christoph Lange, Daniela Maria Cirillo on behalf of the UNITE4TB Consortium
Publicado en: Breath, 2023, ISSN 2073-4735
Editor: European Respiratory Society
DOI: 10.1183/20734735.0226-2022

Artificial intelligence in tuberculosis: a new ally in disease control

Autores: Mairi McClean, Traian Constantin Panciu, Christoph Lange, Raquel Duarte, Fabian Theis
Publicado en: Breathe, Edición 20, 2024, Página(s) 240056, ISSN 1810-6838
Editor: European Respiratory Society
DOI: 10.1183/20734735.0056-2024

Rolling out new anti-tuberculosis drugs without diagnostic capacity

Autores: Tara Ness, Le Hong Van, Ilze Petermane, Raquel Duarte, Christoph Lange, Dick Menzies, Daniela Maria Cirillo
Publicado en: Breathe, Edición 19(2), July, 2023, ISSN 1810-6838
Editor: European Respiratory Society
DOI: 10.1183/20734735.0084-2023

Standards for model-based early bactericidal activity analysis and sample size determination in tuberculosis drug development

Autores: Mockeliunas L, Faraj A, van Wijk RC, Upton CM, van den Hoogen G, Diacon AH, Simonsson USH
Publicado en: Front. Pharmacol., 2023, ISSN 1663-9812
Editor: Frontiers Media S.A.
DOI: 10.3389/fphar.2023.1150243

Other (3)

The biomarker landscape for measuring treatment effect in tuberculosis clinical trials: A systematic review

Autores: Mairi McClean, Leyla Larsson, Alia Razid, Cong Minh Nguyen, Carla Winston, Anna-Lisa Behnke, Norbert Heinrich, Juan Espinosa-Pereiro
Publicado en: 2026
Editor: SSRN

Modelling treatment response in tuberculosis early bactericidal activity trials

Autores: Mairi CW McClean, Simon E Koele, Julia Dreisbach, Susanne Mirold-Mei, Fred Njeleka, Daniel Mapamba, Bariki Mtafya, Patrick PJ Phillips, Veronique R De Jager, Rodney Dawson, Kim Narunsky, Andreas H Diacon, Elin M Svensson, Norbert Heinrich, Francesco Paolo Casale, Michael Hoelscher
Publicado en: 2026
Editor: medRxiv
DOI: 10.64898/2026.01.19.26344385

Blood Transcriptomic and Clinical Biomarkers for Prediction of Tuberculosis Recurrence: A Multi-Country Validation Study​

Autores: Mairi McClean, Olga Baranov, Mohamed I.M. Ahmed, Nadja Bräuer, Ivan Noreña, Beno Mbeya, Stellah Mpagama, Nyanda Elias Ntinginya, Rodney Dawson, A.H. Diacon, Mohammed Rassool, Gavin Churchyard, Jodie Schildkraut, Christof Geldmacher, Francesco Paolo Casale, Norbert Heinrich, Michael Hoelscher, Kathrin Held
Publicado en: 2026
Editor: The Lancet
DOI: 10.2139/ssrn.6574266

Non-peer reviewed articles (1)

UNITE4TB: a new consortium for clinical drug and regimen development for TB

Autores: Boeree, M. J.; Lange, C.; Thwaites, G; Paton, N ; de Vrueh, R.; Barros, D.; Hoelscher, M.; on behalf of the UNITE4TB Consortium
Publicado en: International Union Against Tuberculosis and Lung Disease, Edición Volume 25, Number 11, 1 November 2021, 2021, Página(s) 886-889, ISSN 1027-3719
Editor: International Union Against Tuberculosis And Lung Disease/Union Internationale Contre la Tuberculose et les Maladies Respiratories
DOI: 10.5588/ijtld.21.0515