Skip to main content

EUROPEAN REGIMEN ACCELERATOR FOR TUBERCULOSIS

Deliverables

First study subject approvals package for molecule TBAJ587

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 models

This report will describe molecular signature data obtained during antiTB treatment in selected mouse and NHP models Updates M48 M72

First Report on implementation of selected mouse models for in vivo evaluation of drug candidates

This 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

Project communication plan and initial toolset

A 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 members

Initial 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 package

Includes 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 report

Data collection templates for use by Consortium members for the collection and integration of data

First Report on clinical and preclinical datasets standardized and integrated into the DDIM

First 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 biomarkers

This 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) system

An 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 models

Initial 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 Handbook

Quick 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.

Availability of existing preclinical and clinical TB datasets -interim report

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

Initial molecular imaging systems, procedures and protocols to perform quantitative, dynamic PET/CT studies in BSL3 conditions in NHP models

Initial molecular imaging systems procedures and protocols to perform quantitative dynamic PETCT studies in BSL3 conditions in NHP models Updated M70

Searching for OpenAIRE data...

Publications

In silico designing of vaccine candidate against Clostridium difficile

Author(s): S. Basak, D. Deb, U. Narsaria, T. Kar, F. Castiglione, I. Sanyal, P. D. Bade, A. P. Srivastava
Published in: Scientific Reports, 11, 2021, Page(s) 14215, ISSN 2045-2322
Publisher: Nature Publishing Group
DOI: 10.1038/s41598-021-93305-6

Detection and analysis of COVID-19 in medical images using deep learning techniques

Author(s): Dandi Yang, Cristhian Martinez, Lara Visuña, Hardev Khandhar, Chintan Bhatt, Jesus Carretero
Published in: Scientific Reports, 11/1, 2021, ISSN 2045-2322
Publisher: Nature Publishing Group
DOI: 10.1038/s41598-021-99015-3

Tolerance and Persistence to Drugs: A Main Challenge in the Fight Against Mycobacterium tuberculosis

Author(s): Francesca Boldrin, Roberta Provvedi, Laura Cioetto Mazzabò, Greta Segafreddo, Riccardo Manganelli
Published in: Frontiers in Microbiology, 11, 2020, ISSN 1664-302X
Publisher: Frontiers Media
DOI: 10.3389/fmicb.2020.01924

A candidate multi-epitope vaccine against SARS-CoV-2

Author(s): Tamalika Kar, Utkarsh Narsaria, Srijita Basak, Debashrito Deb, Filippo Castiglione, David M. Mueller, Anurag P. Srivastava
Published in: Scientific Reports, 10/1, 2020, Page(s) 10895, ISSN 2045-2322
Publisher: Nature Publishing Group
DOI: 10.1038/s41598-020-67749-1

From Infection to Immunity: Understanding the Response to SARS-CoV2 Through In-Silico Modeling

Author(s): F. Castiglione, D. Deb, A.P. Srivastava, P. Lio`, A. Liso
Published in: Frontiers in Immunology, 12, 2021, Page(s) 3433-3449, ISSN 1664-3224
Publisher: Frontiers
DOI: 10.3389/fimmu.2021.646972

Difference in persistent tuberculosis bacteria between in vitro and sputum from patients: implications for translational predictions

Author(s): Alan Faraj, Oskar Clewe, Robin J. Svensson, Galina V. Mukamolova, Michael R. Barer, Ulrika S. H. Simonsson
Published in: Scientific Reports, 10/1, 2020, ISSN 2045-2322
Publisher: Nature Publishing Group
DOI: 10.1038/s41598-020-72472-y

Development of an Inverted Epifluorescence Microscope for Long-Term Monitoring of Bacteria in Multiplexed Microfluidic Devices

Author(s): Amaro Torres-Simón, María Henar Marino, Clara Gómez-Cruz, Marina Cañadas, Miguel Marco, Jorge Ripoll, Juan José Vaquero, Arrate Muñoz-Barrutia
Published in: Sensors, 20/15, 2020, Page(s) 4140, ISSN 1424-8220
Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/s20154140