The meeting focused on discussing the results of the ALIVE trial and how to move forward after the project ends
Members of the STOP project gathered in Maputo, southern Mozambique, for the final consortium meeting. The ECTP-funded project, which started five years ago, conducted a clinical trial in Kenya, Mozambique and Ethiopia to test the efficacy of a fixed-dose combination (FDC) of ivermectin and albendazole to treat soil-transmitted helminths (STH) in schoolchildren.
During the two-day meeting (14 and 15 September), the consortium reviewed the safety and efficacy data from the ALIVE trial, where a total of 4,355 children were screened and 994 were randomised and treated with the new drug (FDC) or the standard treatment (albendazole alone). “It was an opportunity to review the lessons learned, and to thank everyone for the hard work they put into the trial,” says Almudena Legarda, scientific coordinator of the project.
The team discussed pending tasks, including upcoming publications of the data from the phase 2/3 trial, the data obtained through the use of molecular techniques to detect the STH, and site-specific results. In addition, the PhD students supported by the project were able to present their current research results and future plans. The meeting ended with a tour of the campus of the Manhiça Health Research Centre (CISM), including the microscopy and molecular diagnostics laboratory.
The final meeting also focused on looking ahead to how the results of the past five years can be used to promote the further study – and use – of the FDC. Importantly, through the recently launched STOP2030 project, also funded by the EDCTP, it will test the safety and effectiveness of the FDC in Mass Drug Administration (MDA) campaigns in Kenya and Ghana. One of the first steps is to prepare the results to submit to the European Medicines Agency (EMA) for approval.
“The final STOP meeting was the occasion to celebrate the successful completion of a project that included a large component of capacity building to conduct clinical trials for NTDs in sub-Saharan Africa” says Jose Muñoz, Principal Investigator of the STOP project.