Risultati finali
Includes final version of study protocol as approved by first regulatorethics committees registration number of clinical study in a WHO or ICMJE approved registry and the approvals required for the enrolment of first subject in at least one clinical centre according to EU and national legislation Study protocol will be developed by SERMAS in collaboration with CTUs and EFPIA partners according to ICHE6R2 Guideline For Good Clinical Practice Scheduled CDGO plus 11 months
First report on molecular signatures of anti-TB drug treatment efficacy in the three animal modelsThis report will describe molecular signature data obtained during antiTB treatment in selected mouse and NHP models Updates M48 M72
Initial report on recommendations for design, dosing and sampling schedule for selected experimental protocols in WPs 2, 3 and 4.An overview of potential limitations will be presented along with the agreed recommendations for optimisation of experimental protocols Update M36
Second Report on clinical and preclinical datasets standardized and integrated into the DDIMSecond report on the quantity and status of datasets integrated into the DSP This report will also serve to provide best practices and lessons learned to drive continuous improvement in the data collaboration processes
Third Report on clinical and preclinical datasets standardized and integrated into the DDIMThird report on the quantity and status of datasets integrated into the DSP. This report will also serve to provide best practices and lessons learned to drive continuous improvement in the data collaboration processes.
First Report on implementation of selected mouse models for in vivo evaluation of drug candidatesThis report will describe the different mouse models that were established optimized in the partners institutions for the in vivo evaluation of new antiTB compounds Updates M24 M48
Second report on implementation of selected mouse models for in vivo evaluation of drug candidatesThis report will describe the different mouse models that were established optimized in the partners institutions for the in vivo evaluation of new antiTB compounds
Project communication plan and initial toolsetA plan for dissemination that includes the communication objectives, target audiences, activities to be carried out and tools that will support their implementation, with connections among these components. It will also include an initial set of communication materials.
Initial standardized templates for collection and reporting of clinical and preclinical data available to consortium membersInitial data collection templates for use by Consortium members for the collection and integration of data. Templates will be generated as soon as possible based on input from Consortium members, and early reviews of the data generated within the Consortium. Data collection templates will evolve throughout the project based on knowledge and experience gained. (Updated M16)
First study subject approvals packageIncludes final version of study protocol as approved by first regulator/ethics committee(s), registration number of clinical study in a WHO- or ICMJE- approved registry and the approvals required for the enrolment of first subject in at least one clinical centre according to EU and national legislation. Study protocol will be developed by SERMAS in collaboration with CTUs and EFPIA partners according to ICH-E6(R2) “Guideline For Good Clinical Practice”. Due date will relate to the Commit Decision to GO (CDGO) for each FTIH trial plus 4 months.
Standardized templates for collection and reporting of clinical and preclinical data available to consortium members -interim reportData collection templates for use by Consortium members for the collection and integration of data
Third report on implementation of selected mouse models for in vivo evaluation of drug candidatesThis report will describe the different mouse models that were established / optimized in the partner’s institutions for the in vivo evaluation of new anti-TB compounds.
First Report on clinical and preclinical datasets standardized and integrated into the DDIMFirst of a series of periodic report on the quantity and status of datasets integrated into the DSP This report will also serve to provide best practices and lessons learned to drive continuous improvement in the data collaboration processes
First Report on discovery and validation of predictive TB biomarkersThis report will describe the results obtained by the various efforts to identify andor validate predictive TB biomarkers Updates M48 M72
Report on instantiation of EU-based Drug Development Information Management (DDIM) systemAn initial report to provide early status on the deployment of the DDIM and the underlying clinical and preclinical data management systems, image store and common user interface.
Initial molecular imaging systems, procedures and protocols to perform quantitative, dynamic PET/CT and NIR imaging studies in BSL3 conditions in mouse modelsInitial report on the molecular imaging systems procedures and protocols to perform quantitative dynamic PETCT and NIR imaging studies in BSL3 conditions in mouse models Updated M70
Project HandbookQuick reference manual for partners to consult management procedures, including relevant provisions of the GA/CA in an easy to understand language. It will also explain the tools set up to facilitate collaborative work across the Consortium.
Development and optimization of NHP models for TB drug efficacy evaluationReport on the efforts made to develop and optimize the marmoset and macaque models for evaluating treatment efficacy of new anti-TB compounds under conditions that closer resemble the situation in humans than murine models.
HFS-TB implementation at UNIZAR to meets industry-level standards for data quality, experimental design and integrity, throughput, analysis, and reporting.
Platform for supervised and automatic image analysisImaging platform to define and quantify translational biomarkers from in vivo PET/CT molecular imaging across species (mouse, NHP and human)
Initial molecular imaging systems, procedures and protocols to perform quantitative, dynamic PET/CT studies in BSL3 conditions in NHP modelsInitial molecular imaging systems procedures and protocols to perform quantitative dynamic PETCT studies in BSL3 conditions in NHP models Updated M70
Efficient pipeline and logistic resources to image infected tissueDemonstration of the use of MALDI-MS imaging technologies and means for sharing the samples with no BSL3 SI services constrains to image infected tissues within the pipeline context.
Negotiations with the owners of legacy clinical and preclinical datasets generated prior to the existence of the ERA4TB Consortium or in parallel will be conducted and if permitted will be made available to consortium members This may occur prior to the full implementation of the DDIM so alternative means for dissemination of this data may be used eg via existing data platforms or temporary databases
Pubblicazioni
Autori:
Lara Visuña, Dandi Yang, Javier Garcia-Blas and Jesus Carretero
Pubblicato in:
BMC medical imaging, 2022, Pagina/e 22, 178., ISSN 1471-2342
Editore:
BioMed Central
DOI:
10.1186/s12880-022-00904-4
Autori:
Chiara Toniolo, Neeraj Dhar, John D McKinney
Pubblicato in:
EMBO Journal, 2023, ISSN 0261-4189
Editore:
Nature Publishing Group
DOI:
10.1101/2023.01.11.523669
Autori:
S. Basak, D. Deb, U. Narsaria, T. Kar, F. Castiglione, I. Sanyal, P. D. Bade, A. P. Srivastava
Pubblicato in:
Scientific Reports, Numero 11, 2021, Pagina/e 14215, ISSN 2045-2322
Editore:
Nature Publishing Group
DOI:
10.1038/s41598-021-93305-6
Autori:
Griego A, Douché T, Gianetto QG, Matondo M, Manina G.
Pubblicato in:
iScience, 2022, Pagina/e Vol. 25Numero 5, ISSN 1097-4172
Editore:
Cell Press
DOI:
10.1016/j.isci.2022.104233
Autori:
Dandi Yang, Cristhian Martinez, Lara Visuña, Hardev Khandhar, Chintan Bhatt, Jesus Carretero
Pubblicato in:
Scientific Reports, Numero 11/1, 2021, ISSN 2045-2322
Editore:
Nature Publishing Group
DOI:
10.1038/s41598-021-99015-3
Autori:
Rob C van Wijk, Ainhoa Lucía, Pavan Kumar Sudhakar, Lindsay Sonnenkalb, Cyril Gaudin, Eik Hoffmann, Bérénice Dremierre, Diana Angélica Aguilar-Ayala, Michael Dal Molin, Jan Rybniker, Stefano de Giorgi, Laura Cioetto-Mazzabò, Greta Segafreddo, Riccardo Manganelli, Giulia Degiacomi, Deborah Recchia, Maria Rosalia Pasca, Ulrika S H Simonsson, Santiago Ramón-García
Pubblicato in:
Nature Communications, Numero 11, 2023, Pagina/e Volume 26, Numero 4, 21 April 2023, 106411, ISSN 2041-1723
Editore:
Nature Publishing Group
DOI:
10.1016/j.isci.2023.106411
Autori:
Francesca Boldrin, Roberta Provvedi, Laura Cioetto Mazzabò, Greta Segafreddo, Riccardo Manganelli
Pubblicato in:
Frontiers in Microbiology, Numero 11, 2020, ISSN 1664-302X
Editore:
Frontiers Media
DOI:
10.3389/fmicb.2020.01924
Autori:
Tamalika Kar, Utkarsh Narsaria, Srijita Basak, Debashrito Deb, Filippo Castiglione, David M. Mueller, Anurag P. Srivastava
Pubblicato in:
Scientific Reports, Numero 10/1, 2020, Pagina/e 10895, ISSN 2045-2322
Editore:
Nature Publishing Group
DOI:
10.1038/s41598-020-67749-1
Autori:
F. Castiglione, D. Deb, A.P. Srivastava, P. Lio`, A. Liso
Pubblicato in:
Frontiers in Immunology, Numero 12, 2021, Pagina/e 3433-3449, ISSN 1664-3224
Editore:
Frontiers
DOI:
10.3389/fimmu.2021.646972
Autori:
Alan Faraj, Oskar Clewe, Robin J. Svensson, Galina V. Mukamolova, Michael R. Barer, Ulrika S. H. Simonsson
Pubblicato in:
Scientific Reports, Numero 10/1, 2020, ISSN 2045-2322
Editore:
Nature Publishing Group
DOI:
10.1038/s41598-020-72472-y
Autori:
Mistretta M, Gangneux N, Manina G.
Pubblicato in:
Scientific Reports, 2022, Pagina/e 19578 (2022), ISSN 2045-2322
Editore:
Nature Publishing Group
DOI:
10.1038/s41598-022-24175-9
Autori:
Amaro Torres-Simón, María Henar Marino, Clara Gómez-Cruz, Marina Cañadas, Miguel Marco, Jorge Ripoll, Juan José Vaquero, Arrate Muñoz-Barrutia
Pubblicato in:
Sensors, Numero 20/15, 2020, Pagina/e 4140, ISSN 1424-8220
Editore:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/s20154140
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