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EUROPEAN REGIMEN ACCELERATOR FOR TUBERCULOSIS

Deliverables

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.

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.

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.

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Publications

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, Issue 11/1, 2021, ISSN 2045-2322
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, Issue 11, 2020, ISSN 1664-302X
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, Issue 10/1, 2020, Page(s) 10895, ISSN 2045-2322
DOI: 10.1038/s41598-020-67749-1

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, Issue 10/1, 2020, ISSN 2045-2322
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, Issue 20/15, 2020, Page(s) 4140, ISSN 1424-8220
DOI: 10.3390/s20154140