At STOP2030 we want to provide a pharmacological tool that helps at delivering WHO’s elimination goals for soil-transmitted helminthiasis (STH). We are happy to announce that we’ve completed the design of the REALISE study (Real world Evaluation of an Albendazole-Ivermectin coformulation Safety and Effectiveness), a clinical trial that will help us advance towards this goal.  

The details of the REALISE study have been published in ClinicalTrials.gov and the Pan African Clinical Trial Registry (id: PACTR202402529220760). This information will soon be submitted to the Institutional Review Boards (IRBs) in Ghana and Kenya, the two countries where patient recruitment and treatment administration will take place. The publication is an important milestone for STOP2030, an EDCTP funded project.

 The design of this clinical trial was led by the teams at ISGlobal and Liconsa, with support from GHS (Ghana Health Service) and KEMRI (Kenya Medical Research Institute) and other partners in our consortium.

The study itself is a Cohort Event Study aimed at evaluating the safety and effectiveness of our fixed-dose coformulation (FDC) of albendazole and ivermectin in a larger cohort than in our already completed pivotal trial. We expect to recruit around 20,000 school-aged children between 5 and 17 years old between the two countries, starting on the second half of 2024.

The general objective of the REALISE study is to validate the benefits of the FDC through this pragmatic trial in a context resembling the conditions of a mass drug administration (MDA) programme. It aims to evaluate its safety as a primary endpoint, and its effectiveness profile as a secondary endpoint, all within a large population of school-aged children.

The clinical trial will have two arms, randomized by school. One arm will receive a single dose of the fixed-dose coformulation tablet (alb 400mg/ivm 9mg for children between 5 and 14 years old, alb 400mg/ivm 18mg for 15-17s), while the other, acting as an active control group, will receive a single dose of albendazole 400mg.

If you want to review the full protocol, please visit the REALISE study’s page at clinicaltrials.gov or PACTR.