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Borja Robert 11 months ago
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- 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
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- ## 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
- Investigadores principales de cada uno de los partners
- 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
-
- Ideas generales importantes
- Dosing strategies for Ivermectine are being revisited
- The fix-dose coformulation of Albendazole/Ivermectine is due to enter regulatory agencies

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