If you want to review the full protocol, please visit the REALISE study's page at clinicaltrials.gov or PACTR.
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- # The REALISE clinical trial is registered
At STOP2030, we aim to provide a pharmacological tool that aids in achieving the WHO's goals for
soil-transmitted helminthiasis (STH) by 2030. That's why we are thrilled to announce that the REALISE study (Real world Evaluation of an ALbendazol-Ivermectin coformulation Safety and Effectiveness), our most ambitious clinical trial yet, has been registered on[clinicaltrials.gov](https://urldefense.com/v3/__https:/clinicaltrials.gov/study/NCT06282315__;!!MxJ9VFnHG7aJbmI!WQUMYoZBne-RmarvmmdxDOX3YMCZphl_SYR6TtQ550bOR1NSAz-QDjW71W8gqwBGC7emXh7iATor5zncW8CTAdM$)and
the[Pan African Clinical Trial
Registry](https://urldefense.com/v3/__https:/pactr.samrc.ac.za/Search.aspx__;!!MxJ9VFnHG7aJbmI!WQUMYoZBne-RmarvmmdxDOX3YMCZphl_SYR6TtQ550bOR1NSAz-QDjW71W8gqwBGC7emXh7iATor5zncACmxOT0$)(id number PACTR202402529220760). This news follows the
approval from the Ghana Health Service Ethical Review Committee, obtained in
December, 2023.
This randomized control trial is a
Cohort Event Monitoring study designed to evaluate the safety and effectiveness
of our fixed-dose coformulation (FDC) of albendazole and ivermectin in large
populations, compared to the standard dose of albendazole currently used
against STH. We plan to recruit around 20,000 school-aged children between 5
and 17 years old in Kenya and Ghana, starting in July 2024.
The general goals of the REALISE
study are to validate the benefits of the FDC through this pragmatic trial
within the context of a mass drug administration (MDA) program, to evaluate
safety as a primary endpoint, and effectiveness profile as a secondary
endpoint, in 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 those aged 15-17), while the other arm,
serving as an active control group, will receive a single dose of albendazole