ACADEMIA AND INDUSTRY UNITED INNOVATION AND TREATMENT FOR TUBERCULOSIS

Informazioni relative al progetto

UNITE4TB

ID dell’accordo di sovvenzione: 101007873

DOI

10.3030/101007873

Data della firma CE 29 Giugno 2021

Data di avvio 1 Giugno 2021

Data di completamento 31 Maggio 2028

Finanziato da

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

Costo totale

€ 185 000 000,00

Contributo UE

€ 92 500 000,00

Coordinato da

STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM
Netherlands

CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.

I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .

Risultati finali

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)

Pubblicazioni

Peer reviewed articles (26)

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

Autori: 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
Pubblicato in: Pharmaceutics, 2022, ISSN 1999-4923
Editore: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics14081530

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

Autori: Suzanne M. Dufault; Angela M. Crook; Katie Rolfe; Patrick P. J. Phillips
Pubblicato in: Statistics in Medicine , 43 (3) pp. 501-513. (2024), Numero 17, 2024, Pagina/e 501-513, ISSN 0277-6715
Editore: John Wiley & Sons Inc.
DOI: 10.1002/sim.9961

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

Autori: Shamsuddeen Yusuf Ma'aruf, Aparna Sharma, Shannon Fox, Raquel Duarte, Christoph Lange, Simon Tiberi
Pubblicato in: Breathe, Numero 22, 2026, Pagina/e 250203, ISSN 1810-6838
Editore: European Respiratory Society
DOI: 10.1183/20734735.0203-2025

Treatment-shortening regimens for tuberculosis: updates and future priorities

Autori: Francesca Saluzzo, Victor Abiola Adepoju, Raquel Duarte, Christoph Lange, Patrick P.J. Phillips
Pubblicato in: Breathe, Numero 19 (3), October, 2023, ISSN 1810-6838
Editore: 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

Autori: A. Vasiliu, F. Saluzzo, J.A. Schildkraut, R. Villar-Hernandez, J.P. Ramos, M. Vieira, G. Thwaites, D.M. Cirillo, C. Lange, R. Duarte
Pubblicato in: IJTLD Open, Numero 3, 2026, Pagina/e 105-107, ISSN 3005-7590
Editore: International Union Against Tuberculosis and Lung Disease
DOI: 10.5588/ijtldopen.25.0651

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

Autori: A. Ghodousi, I. Iannucci, F. Saluzzo, J. Dreisbach, S. Mirold-Mei, M. Hoelscher, D.M. Cirillo
Pubblicato in: IJTLD OPEN, Numero 2, 2025, Pagina/e 604-609, ISSN 3005-7590
Editore: International Union Against Tuberculosis and Lung Disease
DOI: 10.5588/ijtldopen.25.0301

Candidate anti-tuberculosis medicines and regimens under clinical evaluation

Autori: Michael Hoelscher, David Barros-Aguirre, Masoud Dara, Norbert Heinrich, Eugene Sun, Christoph Lange, Simon Tiberi, Charles Wells
Pubblicato in: Clinical Microbiology and Infection, Numero 30, 2024, Pagina/e 1131-1138, ISSN 1198-743X
Editore: 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

Autori: Yu‐Jou Lin, Frances Okibedi, Mats O. Karlsson, Elin M. Svensson
Pubblicato in: CPT: Pharmacometrics &amp; Systems Pharmacology, Numero 15, 2026, Pagina/e e70264, ISSN 2163-8306
Editore: Nature Publishing Group
DOI: 10.1002/psp4.70264

Tuberculosis: current challenges and beyond

Autori: Raquel Villar-Hernández, Arash Ghodousi, Olha Konstantynovska, Raquel Duarte, Christoph Lange, Mario Raviglione on behalf of the UNITE4TB Consortium
Pubblicato in: Breath, 2023, ISSN 2073-4735
Editore: 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

Autori: 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
Pubblicato in: Tuberculosis, Numero 157, 2026, Pagina/e 102744, ISSN 1472-9792
Editore: Churchill Livingstone
DOI: 10.1016/j.tube.2026.102744

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

Autori: Simone Villa, Pierpaolo de Colombani, Lucia Dall’Olio, Giuliano Gargioni, Mario Raviglione
Pubblicato in: BMJ Global Health, Numero 2024;9: e014630, 2024, Pagina/e 1-9, ISSN 2059-7908
Editore: BMJ Journals
DOI: 10.1136/bmjgh-2023-014630

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

Autori: Heyckendorf J, Georghiou SB, Frahm N, Heinrich N, Kontsevaya I, Reimann M, Holtzman D, Imperial M, Cirillo DM, Gillespie SH, Ruhwald M, Consortium UNITE4TB
Pubblicato in: Clinical Microbiology Reviews, Numero 21 March 2022, 2022, Pagina/e n/a, ISSN 1098-6618
Editore: 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

Autori: Alessandra Serra, Thomas Jaki, Pavel Mozgunov
Pubblicato in: Statistics in Biopharmaceutical Research, 2026, Pagina/e 1-23, ISSN 1946-6315
Editore: Informa UK Limited
DOI: 10.1080/19466315.2026.2676642

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

Autori: 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
Pubblicato in: Lancet Microbe, 2024, Pagina/e 1-11, ISSN 2666-5247
Editore: Elsevier ltd.
DOI: 10.1016/s2666-5247(24)00085-5

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

Autori: Alessandra Serra, Pavel Mozgunov, Patrick PJ Phillips, Thomas Jaki
Pubblicato in: Statistical Methods in Medical Research, 2026, ISSN 0962-2802
Editore: SAGE Publications
DOI: 10.1177/09622802261430905

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

Autori: Jodie A. Schildkraut, Niklas Köhler, Christoph Lange, Raquel Duarte, Stephen H. Gillespie
Pubblicato in: Breathe, Numero 20, 2024, Pagina/e 240003, ISSN 1810-6838
Editore: European Respiratory Society
DOI: 10.1183/20734735.0003-2024

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

Autori: Andrii Dudnyk, Wandini Lutchmun, Raquel Duarte, Christoph Lange, Elin M. Svensson
Pubblicato in: Breathe, Numero 21, 2025, Pagina/e 240177, ISSN 1810-6838
Editore: European Respiratory Society
DOI: 10.1183/20734735.0177-2024

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

Autori: Rabbyia Ahmad, João Pedro Ramos, Raquel Duarte, Christoph Lange, Job Van Rest
Pubblicato in: Breathe, Numero 22, 2026, Pagina/e 250173, ISSN 1810-6838
Editore: European Respiratory Society
DOI: 10.1183/20734735.0173-2025

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

Autori: Yu‐Jou Lin, Louvina E. van der Laan, Mats O. Karlsson, Anthony J. Garcia‐Prats, Anneke C. Hesseling, Elin M. Svensson
Pubblicato in: Clinical Pharmacology &amp; Therapeutics, Numero 117, 2025, Pagina/e 1292-1302, ISSN 0009-9236
Editore: Nature Publishing Group
DOI: 10.1002/cpt.3536

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

Autori: Emily Behrens, Sebastian G. Wicha
Pubblicato in: Journal of Pharmacokinetics and Pharmacodynamics, Numero 52, 2025, ISSN 1567-567X
Editore: Kluwer Academic/Plenum Publishers
DOI: 10.1007/s10928-025-09966-7

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

Autori: 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
Pubblicato in: Nature Reviews Drug Discovery, Numero 24, 2025, Pagina/e 1-2, ISSN 1474-1776
Editore: Nature Publishing Group
DOI: 10.1038/d41573-024-00138-9

Enhancing collaboration between national TB programmes and researchers

Autori: L. Dall’Olio, P. de Colombani, J. Servello, G. Gargioni, R. Duarte, M. Raviglione
Pubblicato in: IJTLD Open, Numero 3, 2026, Pagina/e 111-113, ISSN 3005-7590
Editore: 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

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

Artificial intelligence in tuberculosis: a new ally in disease control

Autori: Mairi McClean, Traian Constantin Panciu, Christoph Lange, Raquel Duarte, Fabian Theis
Pubblicato in: Breathe, Numero 20, 2024, Pagina/e 240056, ISSN 1810-6838
Editore: European Respiratory Society
DOI: 10.1183/20734735.0056-2024

Rolling out new anti-tuberculosis drugs without diagnostic capacity

Autori: Tara Ness, Le Hong Van, Ilze Petermane, Raquel Duarte, Christoph Lange, Dick Menzies, Daniela Maria Cirillo
Pubblicato in: Breathe, Numero 19(2), July, 2023, ISSN 1810-6838
Editore: 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

Autori: Mockeliunas L, Faraj A, van Wijk RC, Upton CM, van den Hoogen G, Diacon AH, Simonsson USH
Pubblicato in: Front. Pharmacol., 2023, ISSN 1663-9812
Editore: 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

Autori: Mairi McClean, Leyla Larsson, Alia Razid, Cong Minh Nguyen, Carla Winston, Anna-Lisa Behnke, Norbert Heinrich, Juan Espinosa-Pereiro
Pubblicato in: 2026
Editore: SSRN

Modelling treatment response in tuberculosis early bactericidal activity trials

Autori: 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
Pubblicato in: 2026
Editore: medRxiv
DOI: 10.64898/2026.01.19.26344385

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

Autori: 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
Pubblicato in: 2026
Editore: The Lancet
DOI: 10.2139/ssrn.6574266

Non-peer reviewed articles (1)

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

Autori: Boeree, M. J.; Lange, C.; Thwaites, G; Paton, N ; de Vrueh, R.; Barros, D.; Hoelscher, M.; on behalf of the UNITE4TB Consortium
Pubblicato in: International Union Against Tuberculosis and Lung Disease, Numero Volume 25, Number 11, 1 November 2021, 2021, Pagina/e 886-889, ISSN 1027-3719
Editore: International Union Against Tuberculosis And Lung Disease/Union Internationale Contre la Tuberculose et les Maladies Respiratories
DOI: 10.5588/ijtld.21.0515