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Borja Robert 10 months ago
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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 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 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 400mg, the current standard.
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
400mg, the current standard.
If you want to review the full protocol, please visit the REALISE study's page on clinicaltrials.gov or PACTR (trial id: PACTR202402529220760).
#+END_VERSE
If you want to review the full
protocol, please visit the REALISE study's page on [clinicaltrials.gov](https://urldefense.com/v3/__http:/clinicaltrials.gov/__;!!MxJ9VFnHG7aJbmI!WQUMYoZBne-RmarvmmdxDOX3YMCZphl_SYR6TtQ550bOR1NSAz-QDjW71W8gqwBGC7emXh7iATor5zncV4ibvmQ$) or PACTR (trial id:
PACTR202402529220760).
#+END_VERSE At STOP2030, we aim to provide a pharmacological tool that aids in achieving the WHO's goals for soil-transmitted helminthiasis (STH) by 2030. That's why we are thrilled to announce that the REALISE study (Real world Evaluation of an ALbendazol-Ivermectin coformulation Safety and Effectiveness), our most ambitious clinical trial yet, has been registered on clinicaltrials.gov and the Pan African Clinical Trial Registry (id number PACTR202402529220760).
This randomized control trial is a Cohort Event Monitoring study designed to evaluate the safety and effectiveness of our fixed-dose coformulation (FDC) of albendazole and ivermectin in large
populations, compared to the standard dose of albendazole currently used against STH. We plan to recruit around 20,000 school-aged children between 5 and 17 years old in Kenya and Ghana, starting the the second semester of 2024.
The general goals of the REALISE study are to validate the benefits of the FDC through this pragmatic trial within the context of a mass drug administration (MDA) program, to evaluate safety as a primary endpoint, and effectiveness profile as a secondary endpoint, in a large population of school-aged children.
The clinical trial will have two
arms, randomized by school. One arm will receive a single dose of the
fixed-dose coformulation tablet (alb 400mg/ivm 9mg for children between 5 and
14 years old; alb 400mg/ivm 18mg for those aged 15-17), while the other arm,
serving as an active control group, will receive a single dose of albendazole
400mg, the current standard.
If you want to review the full
protocol, please visit the REALISE study's page on [clinicaltrials.gov](https://urldefense.com/v3/__http:/clinicaltrials.gov/__;!!MxJ9VFnHG7aJbmI!WQUMYoZBne-RmarvmmdxDOX3YMCZphl_SYR6TtQ550bOR1NSAz-QDjW71W8gqwBGC7emXh7iATor5zncV4ibvmQ$) or PACTR (trial id:
PACTR202402529220760).
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