From 0ec9685a2bc66dc10e5c5dcaadee0059944c68de Mon Sep 17 00:00:00 2001 From: Borja Robert Date: Mon, 19 Feb 2024 16:08:36 +0100 Subject: [PATCH] Auto saved by Logseq --- pages/STOP2030___Web.md | 40 ++++++++++++++++++++-------------------- 1 file changed, 20 insertions(+), 20 deletions(-) diff --git a/pages/STOP2030___Web.md b/pages/STOP2030___Web.md index 9efbc182..52b0249d 100644 --- a/pages/STOP2030___Web.md +++ b/pages/STOP2030___Web.md @@ -13,30 +13,30 @@ - Develop a model for sustainable supply and costing - Model the impact of different use cases and scenarios - Pilot antihelmintic resistance surveillance based on genetic epidemiology + - ## Timeline y milestones (cuáles se han cumplido?) + - __Proposed safety and effectiveness study__ + - *Primary objective*: To evaluate and compare safety of a [[FDC]] against [[Albendazole]] alone via [[MDA]] in two study areas in Kenya and [[Ghana]]. + - *Secondary objectives*: + - To evaluate the effectiveness of one round of [[MDA]] with [[FDC]] vs [[Albendazole]] against [[STH]] (T. trichiura, A. lumbricoides, hookworms) [[by]] microscopy + - To evaluate the effectiveness of one round of [[MDA]] with [[FDC]] vs [[Albendazole]] against [[Strongyloides stercolaris]] [[by]] serology + - *Primary goal*: Safety (incidence of SAEs) + - *Secondary goals*: Effectiveness at 21 days and 1 [[year]]; Genomic resistance + - *Sample size*: approx. 20k. + - *Target population*: School based + - *Epidemiologic conditions of the sites*: T. trichiura ongoing transmission areas + - *Countries*: [[Ghana]] and [[Kenya]] + - __Proposed acceptability and feasibility study__ + - *Primary goal*: Acceptability and feasibility + - *Secondary goals*: Adherence (3-day regimen), fidelity + - *Countries*: [[Ghana]] and [[Kenya]] + - *Epidemiologic conditions of the sites*: Ongoing [[STH]] deworming activities + - - ## Objetivos y logros de los proyectos STOP previos (en background) - Qualification at EMA for art. 58 - Safety of IVM up to 600μg/kg alone and in coformulation with albendazole - Demonstrated efficacy agrainst T. trichiura in a pivotal trial in Sub-Saharan Africa - - Timeline y milestones (cuáles se han cumplido?) - - __Proposed safety and effectiveness study__ - - *Primary objective*: To evaluate and compare safety of a [[FDC]] against [[Albendazole]] alone via [[MDA]] in two study areas in Kenya and [[Ghana]]. - - *Secondary objectives*: - - To evaluate the effectiveness of one round of [[MDA]] with [[FDC]] vs [[Albendazole]] against [[STH]] (T. trichiura, A. lumbricoides, hookworms) [[by]] microscopy - - To evaluate the effectiveness of one round of [[MDA]] with [[FDC]] vs [[Albendazole]] against [[Strongyloides stercolaris]] [[by]] serology - - *Primary goal*: Safety (incidence of SAEs) - - *Secondary goals*: Effectiveness at 21 days and 1 [[year]]; Genomic resistance - - *Sample size*: approx. 20k. - - *Target population*: School based - - *Epidemiologic conditions of the sites*: T. trichiura ongoing transmission areas - - *Countries*: [[Ghana]] and [[Kenya]] - - __Proposed acceptability and feasibility study__ - - *Primary goal*: Acceptability and feasibility - - *Secondary goals*: Adherence (3-day regimen), fidelity - - *Countries*: [[Ghana]] and [[Kenya]] - - *Epidemiologic conditions of the sites*: Ongoing [[STH]] deworming activities - - - - ## FDC of ivm/alb has the lowest level of investment risk of all candidates for Combination for STH treatment (STH Drug Combinations Expert Meeting, BMGF, April 2016) - - Main results of previous STOP projects: ALIVE pivotal Trial + - ## Otros facts + - FDC of ivm/alb has the lowest level of investment risk of all candidates for Combination for STH treatment (STH Drug Combinations Expert Meeting, BMGF, April 2016) - Investigadores principales de cada uno de los partners - Ideas generales importantes - Dosing strategies for Ivermectine are being revisited