Aurum is an independent non-profit institute dedicated to solving health problems of the poor through research and implementation. It is based in Johannesburg, South Africa. Aurum has overall responsibility for this project.
0%
The Aurum Institute
PROJECT MANAGEMENT
OBJECTIVES
To perform core administrative, financial, reporting, ethical and regulatory functions, and to facilitate other work packages.
DESCRIPTION OF WORK TO BE CONDUCTED
As lead, Aurum will arrange contracts with participants and contractors, arrange trial insurance, establish billing and other accounting procedures, arrange meetings with FDA and EMA, perform local ethical and regulatory submissions and updates, assist other sites in similar submissions, arrange annual meetings and training activities, arrange TSC and DSMB meetings, and prepare recruitment and other periodic reports. Other participants will establish grant and financial management procedures, execute them, and perform local ethical and regulatory submissions as a part of this work package.
CLINICAL STUDY
OBJECTIVES
To screen, enroll, treat, and evaluate patients as described in the study protocol.
DESCRIPTION OF WORK TO BE CONDUCTED
All clinical sites will screen and enroll patients and perform study evaluations. As lead, Aurum will also prepare the study protocol and supervise monitoring activities to ensure study start (including site assessments and initiation visits), execution (including monitoring assessments using a risk-based system), and close-out (including data cleaning and archiving) conform to protocol specifications and international standards.
DISSEMINATION AND EXPLOITATION
OBJECTIVES
To communicate regarding ongoing study activities, disseminate key study findings, and exploit knowledge gained to maximize impact
DESCRIPTION OF WORK TO BE CONDUCTED
This will include creation of a project website and newsletter, writing and submission of abstracts, presentations and manuscripts, and coordination of activities with professional, normative, and governmental organizations.
MODELLING
OBJECTIVES
To assess short and long-term population health impact.
DESCRIPTION OF WORK TO BE CONDUCTED
Working with Nick Menzies, an Associate Professor of Global Health in the Department of Global Health and Population at Harvard University`s Center for Health Decision Science to adapt a published mathematical model of TB to estimate the short-term effects of a new regimen on likelihood of cure, and the long-term population health benefits, compared to standard of care to the populations of South Africa and Mozambique. The initial modelling will use data from the Gates TB-HDT study to identify key data and components with greatest uncertainty. This will inform the final protocol for the clinical trial as well as the updated modelling, which will use data collected in this trial.
CHEMISTRY, MANUFACTURING AND CONTROL (CMC)
OBJECTIVES
To synthesize drug substance and manufacture 200,000 sutezolid 200mg tablets under GMP conditions for use in the trial.
DESCRIPTION OF WORK TO BE CONDUCTED
Aurum and Sequella jointly identified TB Alliance as the suitable vendor(s) to synthesize, tablet, package, and stability test sutezolid tablets. The tablets were developed at Piramal Pharma Limited in India at using TB Alliance methods.
This project [RIA2019AMR-2647] is part of the EDCTP2 Programme supported by the European Union 
Copyright © 2022 panTB-HM | Designed by Aproface
