A PanACEA Capacity Development Project
MMRC: Site Principal Investigator: Andrea Rachow, MD, Co-Site PI: Issa Sabi
Munich: Protocol Chair: Norbert Heinrich
Purpose
Early Bactericidal Activity (EBA) Studies are currently the eye of the needle in the anti-TB drug development process, with limited site capacity slowing down phase 2 testing of new anti-TB drug candidates. To address this problem, PanACEA (Pan-African Consortium for Evaluation of Antituberculosis Antibiotics) has decided to develop a Tanzanian EBA facility consisting of MMRC and Kilimanjaro Clinical Research Institute (KCRI).
OEBA is designed as a platform to establish capacity for Early Bactericidal Activity Studies in these sites, and will provide the opportunity to research additional questions around TB treatment and monitoring of treatment success.
Approach
The sites are developing their inpatient facilities, train laboratory and clinical staff, and demonstrate the capabilities within this two-site study, which will apply the methodologies to patients newly started on standard anti-TB treatment. The results of this study will demonstrate that EBA studies are feasible in the two-site setting in Tanzania.
Results
Tthe protocol has been finalized in 3Q 2010, and is currently undergoing ethical review.
Sponsors
Tthe study is sponsored by the European and Developing Countries Clinical Trials Partnership (EDCTP), within the PanACEA capacity development plan.
Partners
Kilimanjaro Clinical Research Institute, Radboud University Nijmegen, the Netherlands, University College of London
Publications
no publications yet
