From 3b5317104ecd489d7bfedcde0f9caf9d3c13dd05 Mon Sep 17 00:00:00 2001 From: Borja Robert Date: Thu, 21 Mar 2024 14:19:59 +0100 Subject: [PATCH] Auto saved by Logseq --- pages/STOP2030___Web___Posts.md | 23 +++++++++++++++++++---- 1 file changed, 19 insertions(+), 4 deletions(-) diff --git a/pages/STOP2030___Web___Posts.md b/pages/STOP2030___Web___Posts.md index 4efaaf2c..ba0718d9 100644 --- a/pages/STOP2030___Web___Posts.md +++ b/pages/STOP2030___Web___Posts.md @@ -15,10 +15,25 @@ #+END_VERSE - ## 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:/clinicaltrials.gov/study/NCT06282315__;!!MxJ9VFnHG7aJbmI!WQUMYoZBne-RmarvmmdxDOX3YMCZphl_SYR6TtQ550bOR1NSAz-QDjW71W8gqwBGC7emXh7iATor5zncW8CTAdM$) and the [Pan African Clinical Trial - Registry](https:/pactr.samrc.ac.za/Search.aspx__;!!MxJ9VFnHG7aJbmI!WQUMYoZBne-RmarvmmdxDOX3YMCZphl_SYR6TtQ550bOR1NSAz-QDjW71W8gqwBGC7emXh7iATor5zncACmxOT0$) (id number PACTR202402529220760). + - #+BEGIN_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). + #+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.