ACADEMIA AND INDUSTRY UNITED INNOVATION AND TREATMENT FOR TUBERCULOSIS

Informacje na temat projektu

UNITE4TB

Identyfikator umowy o grant: 101007873

DOI

10.3030/101007873

Data podpisania przez KE 29 Czerwca 2021

Data rozpoczęcia 1 Czerwca 2021

Data zakończenia 31 Maja 2028

Finansowanie w ramach

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

Koszt całkowity

€ 185 000 000,00

Wkład UE

€ 92 500 000,00

Koordynowany przez

STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM
Netherlands

CORDIS oferuje możliwość skorzystania z odnośników do publicznie dostępnych publikacji i rezultatów projektów realizowanych w ramach programów ramowych HORYZONT.

Odnośniki do rezultatów i publikacji związanych z poszczególnymi projektami 7PR, a także odnośniki do niektórych konkretnych kategorii wyników, takich jak zbiory danych i oprogramowanie, są dynamicznie pobierane z systemu OpenAIRE .

Rezultaty

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)

Publikacje

Peer reviewed articles (30)

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

Autorzy: 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
Opublikowane w: Pharmaceutics, 2022, ISSN 1999-4923
Wydawca: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics14081530

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

Autorzy: Innocent G. Asiimwe, Tao You, Daniel F. Carr, Munir Pirmohamed, Geraint Davies, Andrea L. Jorgensen, null null
Opublikowane w: Clinical Pharmacology & Therapeutics, Numer 119, 2026, Strona(/y) 964-978, ISSN 0009-9236
Wydawca: 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

Autorzy: Suzanne M. Dufault; Angela M. Crook; Katie Rolfe; Patrick P. J. Phillips
Opublikowane w: Statistics in Medicine , 43 (3) pp. 501-513. (2024), Numer 17, 2024, Strona(/y) 501-513, ISSN 0277-6715
Wydawca: John Wiley & Sons Inc.
DOI: 10.1002/sim.9961

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

Autorzy: Shamsuddeen Yusuf Ma'aruf, Aparna Sharma, Shannon Fox, Raquel Duarte, Christoph Lange, Simon Tiberi
Opublikowane w: Breathe, Numer 22, 2026, Strona(/y) 250203, ISSN 1810-6838
Wydawca: European Respiratory Society
DOI: 10.1183/20734735.0203-2025

Treatment-shortening regimens for tuberculosis: updates and future priorities

Autorzy: Francesca Saluzzo, Victor Abiola Adepoju, Raquel Duarte, Christoph Lange, Patrick P.J. Phillips
Opublikowane w: Breathe, Numer 19 (3), October, 2023, ISSN 1810-6838
Wydawca: 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

Autorzy: A. Vasiliu, F. Saluzzo, J.A. Schildkraut, R. Villar-Hernandez, J.P. Ramos, M. Vieira, G. Thwaites, D.M. Cirillo, C. Lange, R. Duarte
Opublikowane w: IJTLD Open, Numer 3, 2026, Strona(/y) 105-107, ISSN 3005-7590
Wydawca: International Union Against Tuberculosis and Lung Disease
DOI: 10.5588/ijtldopen.25.0651

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

Autorzy: J. Servello, P. de Colombani, L. Dall’Olio, G. Gargioni, M.C.B. Raviglione
Opublikowane w: IJTLD Open, Numer 3, 2026, Strona(/y) 122-137, ISSN 3005-7590
Wydawca: 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

Autorzy: A. Ghodousi, I. Iannucci, F. Saluzzo, J. Dreisbach, S. Mirold-Mei, M. Hoelscher, D.M. Cirillo
Opublikowane w: IJTLD OPEN, Numer 2, 2025, Strona(/y) 604-609, ISSN 3005-7590
Wydawca: International Union Against Tuberculosis and Lung Disease
DOI: 10.5588/ijtldopen.25.0301

Candidate anti-tuberculosis medicines and regimens under clinical evaluation

Autorzy: Michael Hoelscher, David Barros-Aguirre, Masoud Dara, Norbert Heinrich, Eugene Sun, Christoph Lange, Simon Tiberi, Charles Wells
Opublikowane w: Clinical Microbiology and Infection, Numer 30, 2024, Strona(/y) 1131-1138, ISSN 1198-743X
Wydawca: 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

Autorzy: Yu‐Jou Lin, Frances Okibedi, Mats O. Karlsson, Elin M. Svensson
Opublikowane w: CPT: Pharmacometrics &amp; Systems Pharmacology, Numer 15, 2026, Strona(/y) e70264, ISSN 2163-8306
Wydawca: Nature Publishing Group
DOI: 10.1002/psp4.70264

Tuberculosis: current challenges and beyond

Autorzy: Raquel Villar-Hernández, Arash Ghodousi, Olha Konstantynovska, Raquel Duarte, Christoph Lange, Mario Raviglione on behalf of the UNITE4TB Consortium
Opublikowane w: Breath, 2023, ISSN 2073-4735
Wydawca: 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

Autorzy: 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
Opublikowane w: Tuberculosis, Numer 157, 2026, Strona(/y) 102744, ISSN 1472-9792
Wydawca: Churchill Livingstone
DOI: 10.1016/j.tube.2026.102744

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

Autorzy: Simone Villa, Pierpaolo de Colombani, Lucia Dall’Olio, Giuliano Gargioni, Mario Raviglione
Opublikowane w: BMJ Global Health, Numer 2024;9: e014630, 2024, Strona(/y) 1-9, ISSN 2059-7908
Wydawca: BMJ Journals
DOI: 10.1136/bmjgh-2023-014630

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

Autorzy: Heyckendorf J, Georghiou SB, Frahm N, Heinrich N, Kontsevaya I, Reimann M, Holtzman D, Imperial M, Cirillo DM, Gillespie SH, Ruhwald M, Consortium UNITE4TB
Opublikowane w: Clinical Microbiology Reviews, Numer 21 March 2022, 2022, Strona(/y) n/a, ISSN 1098-6618
Wydawca: 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

Autorzy: Alessandra Serra, Thomas Jaki, Pavel Mozgunov
Opublikowane w: Statistics in Biopharmaceutical Research, 2026, Strona(/y) 1-23, ISSN 1946-6315
Wydawca: Informa UK Limited
DOI: 10.1080/19466315.2026.2676642

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

Autorzy: 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
Opublikowane w: Lancet Microbe, 2024, Strona(/y) 1-11, ISSN 2666-5247
Wydawca: Elsevier ltd.
DOI: 10.1016/s2666-5247(24)00085-5

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

Autorzy: Alessandra Serra, Pavel Mozgunov, Patrick PJ Phillips, Thomas Jaki
Opublikowane w: Statistical Methods in Medical Research, 2026, ISSN 0962-2802
Wydawca: SAGE Publications
DOI: 10.1177/09622802261430905

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

Autorzy: Jodie A. Schildkraut, Niklas Köhler, Christoph Lange, Raquel Duarte, Stephen H. Gillespie
Opublikowane w: Breathe, Numer 20, 2024, Strona(/y) 240003, ISSN 1810-6838
Wydawca: European Respiratory Society
DOI: 10.1183/20734735.0003-2024

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

Autorzy: Andrii Dudnyk, Wandini Lutchmun, Raquel Duarte, Christoph Lange, Elin M. Svensson
Opublikowane w: Breathe, Numer 21, 2025, Strona(/y) 240177, ISSN 1810-6838
Wydawca: European Respiratory Society
DOI: 10.1183/20734735.0177-2024

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

Autorzy: Rabbyia Ahmad, João Pedro Ramos, Raquel Duarte, Christoph Lange, Job Van Rest
Opublikowane w: Breathe, Numer 22, 2026, Strona(/y) 250173, ISSN 1810-6838
Wydawca: European Respiratory Society
DOI: 10.1183/20734735.0173-2025

Rising bedaquiline resistance: exploring potential causes and next steps

Autorzy: Jodie A. Schildkraut, Debra Flood, Derek J. Sloan, Norbert Heinrich, Shannon Fox, Christoph Lange, Charles Wells, Simon Tiberi
Opublikowane w: European Respiratory Journal, Numer 67, 2026, Strona(/y) 2501531, ISSN 0903-1936
Wydawca: 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

Autorzy: Yu‐Jou Lin, Louvina E. van der Laan, Mats O. Karlsson, Anthony J. Garcia‐Prats, Anneke C. Hesseling, Elin M. Svensson
Opublikowane w: Clinical Pharmacology &amp; Therapeutics, Numer 117, 2025, Strona(/y) 1292-1302, ISSN 0009-9236
Wydawca: Nature Publishing Group
DOI: 10.1002/cpt.3536

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

Autorzy: Emily Behrens, Sebastian G. Wicha
Opublikowane w: Journal of Pharmacokinetics and Pharmacodynamics, Numer 52, 2025, ISSN 1567-567X
Wydawca: 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

Autorzy: Tra My Pham, Angela M. Crook, Katie Rolfe, Patrick P.J. Phillips, Suzanne M. Dufault, Matteo Quartagno
Opublikowane w: Contemporary Clinical Trials, Numer 155, 2026, Strona(/y) 108002, ISSN 1551-7144
Wydawca: Elsevier BV
DOI: 10.1016/j.cct.2025.108002

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

Autorzy: 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
Opublikowane w: Nature Reviews Drug Discovery, Numer 24, 2025, Strona(/y) 1-2, ISSN 1474-1776
Wydawca: Nature Publishing Group
DOI: 10.1038/d41573-024-00138-9

Enhancing collaboration between national TB programmes and researchers

Autorzy: L. Dall’Olio, P. de Colombani, J. Servello, G. Gargioni, R. Duarte, M. Raviglione
Opublikowane w: IJTLD Open, Numer 3, 2026, Strona(/y) 111-113, ISSN 3005-7590
Wydawca: 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

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

Artificial intelligence in tuberculosis: a new ally in disease control

Autorzy: Mairi McClean, Traian Constantin Panciu, Christoph Lange, Raquel Duarte, Fabian Theis
Opublikowane w: Breathe, Numer 20, 2024, Strona(/y) 240056, ISSN 1810-6838
Wydawca: European Respiratory Society
DOI: 10.1183/20734735.0056-2024

Rolling out new anti-tuberculosis drugs without diagnostic capacity

Autorzy: Tara Ness, Le Hong Van, Ilze Petermane, Raquel Duarte, Christoph Lange, Dick Menzies, Daniela Maria Cirillo
Opublikowane w: Breathe, Numer 19(2), July, 2023, ISSN 1810-6838
Wydawca: 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

Autorzy: Mockeliunas L, Faraj A, van Wijk RC, Upton CM, van den Hoogen G, Diacon AH, Simonsson USH
Opublikowane w: Front. Pharmacol., 2023, ISSN 1663-9812
Wydawca: 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

Autorzy: Mairi McClean, Leyla Larsson, Alia Razid, Cong Minh Nguyen, Carla Winston, Anna-Lisa Behnke, Norbert Heinrich, Juan Espinosa-Pereiro
Opublikowane w: 2026
Wydawca: SSRN

Modelling treatment response in tuberculosis early bactericidal activity trials

Autorzy: 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
Opublikowane w: 2026
Wydawca: medRxiv
DOI: 10.64898/2026.01.19.26344385

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

Autorzy: 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
Opublikowane w: 2026
Wydawca: The Lancet
DOI: 10.2139/ssrn.6574266

Non-peer reviewed articles (1)

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

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