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30 lines
2.2 KiB
Markdown
30 lines
2.2 KiB
Markdown
# [[2024/02/19]] Propuestas de cambios
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- Hay que dejar claro que es un proyecto y ser mucho más concreto sobre los detalles del proyecto. No solo vaguedades.
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- Hay que incluir
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- Objetivos generales y objetivos específicos del proyecto.
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- *Overall goal*: Support the achievement of the [[WHO]] 2030 NTD Roadmap for [[STH]] and beyond
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- *Project purpose*: Advance and accelerate an innovative pharmacological tool to support the elimination goals against [[STH]] species, specially those poorly responsive to current treatment regimens
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- *The intervention*: A single tablet, [[Fixed-Dose Combination]] of Ivermectin and [[Albendazole]]
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- *Specific objectives*:
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- Provide a tool to support the achievement of the [[WHO]] Roadmap goals for [[STH]]
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- Submission process of [[FDC]] to EMA & national agencies in [[Ghana]] and Kenya
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- Safety and effectiveness tailored to policy makers for the control of [[STH]], including [[Strongyloides stercolaris]] and integration with other NTDs
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- Acceptability, feasibility and adherence data added to the evidence package to support [[WHO]] guidance
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- Develop a model for sustainable supply and costing
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- Model the impact of different use cases and scenarios
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- Pilot antihelmintic resistance surveillance based on genetic epidemiology
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- Investigadores principales de cada uno de los partners
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- Timeline y milestones (cuáles se han cumplido?)
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- Proposed safety and effectiveness study
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- *Primary objective*: To evaluate and compare safety of a [[FDC]] against [[Albendazole]] alone via [[MDA]] in two study areas in Kenya and [[Ghana]].
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- *Secondary objectives*:
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- To evaluate the effectiveness of one round of [[MDA]] with [[FDC]] vs [[Albendazole]] against [[STH]] (T. trichiura, A. lumbricoides, hookworms) [[by]] microscopy
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- To evaluate the effectiveness of one round of [[MDA]] with [[FDC]] vs [[Albendazole]] against [[Strongyloides stercolaris]] [[by]] serology
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- *Primary goal*: Safety (incidence of SAEs)
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- *Secondary goals*: Effectiveness at 21 days and 1 [[year]]; Genomic resistance
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- *Sample size*: approx. 20k.
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- *Target population*: School based
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- *Epidemiologic conditions of the sites*: T. trichiura ongoing transmission areas
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- *Countries*:
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