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LogseqFMS/pages/STOP2030___Web___Update 202...

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Cambios 2024/02

- ## Mensaje de [[Ale]] el [[2024/02/20]]
	- #+BEGIN_VERSE
	  Hola Borja. De acuerdo en moverlo en esta dirección. Busquemos que el proyecto sea **reconocible por sus actividades y gente** lo antes posible, y poder usarla para **generar colaboraciones y claridad en el ámbito de salud global y NTDs** .
	  
	  Van respuestas en rojo intercaladas a tus comentarios.
	  
	  Tenemos pendiente definir que hacer con las [[Redes sociales]]. Ya van 8 meses de proyecto y podemos hacer un balance.
	  
	  Destacaría el Estudio ALIVE en la página inicial.
	  
	  Y sumar a los nombres de la gente. Arranquemos con el Steering Committee y pidiendo datos, opiniones, fotos, CV; lo que mejor les parezca.
	  
	  Hasta se podría reflejar Annual meeting, visitas a [[WHO]] y a [[Ghana]] si se busca dar algo de color
	  
	  #+END_VERSE
	-
- Hay que incorporar mucha información técnica que permita a otros investigadores conocer los detalles del proyecto. La web no es solo para público general.
- Asuntos a incluir:
	- ## Objetivos generales y objetivos específicos del proyecto.
		- *Overall goal*: Support the achievement of the [[WHO]] 2030 NTD Roadmap for [[STH]] and beyond
		- *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
		- *The intervention*: A single tablet, [[Fixed-Dose Combination]] of Ivermectin and [[Albendazole]]
		- *Specific objectives*:
			- Provide a tool to support the achievement of the [[WHO]] Roadmap goals for [[STH]]
			- Submission process of [[FDC]] to EMA & national agencies in [[Ghana]] and Kenya
			- Safety and effectiveness tailored to policy makers for the control of [[STH]], including [[Strongyloides stercolaris]] and integration with other NTDs
			- Acceptability, feasibility and adherence data added to the evidence package to support [[WHO]] guidance
			- 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
	- ## Basic facts del proyecto
		- En qué call de EDCTP (Global Health EDCTP3) ha salido
		- Project duration (36 months); cuando empieza y cuando acaba (20 junio 2026)
		- Cuáles son los Work Packages y quién los lidera
	- ## 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 against T. trichiura in a pivotal trial in Sub-Saharan Africa
		- No stopping rules were reached
		- Safety was adequate
		- Palatability results confirm adecuacy of size, taste and smell
		- Superior efficacy against T. trichiura confirms a comprehensive spectrum against STH
		- Los papers más relevantes que salieran de los previos STOP
	- ## 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)
		- Dosing strategies for Ivermectine are being revisited
		- The fix-dose coformulation of Albendazole/Ivermectine is due to enter regulatory agencies
		- Acceptability and safety studies are underway
		- The access plan is being developed
		- Integration across programs (these results have implications beyond STH)
		- Progress has been achieved through public-private partnerships but more partners are needed to reach the ultimate goal.
	- ## Investigadores principales de cada uno de los partners
		- TODO Mandar un email y pedirles nombres para saber a quiénes citamos en la web y cómo quieren que los mostremos (Foto? enlace a LinkedIn? a página personal de su institución? crear una pequeña bio de cada uno en la web de stop2030?)
	- ## Abstract del proyecto
		- [[Soil-Transmitted Helminths]] (STH) remain a significant public health problem with recognized obstacles for control and elimination with the current benzimidazole regimens in [[Mass Drug Administration]] (MDA) campaigns. Renewed targets from [[WHO]] for 2030 include elimination of [[STH]] morbidity in pre-school and school age children (PSAC & SAC), increased country governance and financial support and a strongyloidiasis control program; 2030 has also been targeted by [[WHO]] for controlling NTDs to attain the Sustainable Development Goals. 
		  
		  The current proposal aims at accelerating the implementation of an innovative [[health]] technology, a [[Fixed-Dose Combination]] (FDC) tablet of co-formulated [[albendazole]] and ivermectin, with adequate safety and significantly superior efficacy against T. trichiura in a registrational randomized clinical trial. This trial is being conducted in Ethiopia, [[Kenya]] and Mozambique with the guidance of EMA and sponsored [[by]] [[EDCTP]] (STOP projects) with a Phase II trial completed and a Phase III currently recruiting. 
		  
		  This [[project]], [[STOP2030]], seeks to complement the results of the safety and efficacy trial with a field-based safety and effectiveness clinical study, acceptability studies in [[Ghana]] and [[Kenya]], modelling and cost-effectiveness exercises. The resulting information will be consolidated to build a multidisciplinary package for policy making and [[WHO]] guidance with the support of advocacy and communication activities to reach stakeholders and maximize the exploitation and impact of the [[FDC]] for [[STH]] control and elimination. 
		  
		  The Consortium assembled to execute the [[STOP2030]] proposal combines expertise in complementary fields [[from]] program assessment and implementation through Ministries of [[Health]] in sub Saharan African countries, advocacy, state of the art technology, leadership in clinical research and a pharma that has shown commitment for generating access to drugs against NTDs and has recently obtained [[WHO]] prequalification for generic ivermectin #INFO
	-
	-

  • Mensaje a Nerea con las instrucciones

    • Hola, Nerea: Te adjunto las instrucciones de lo que tenemos que empezar a cambiar de la página web:
    • La clave está en hacer énfasis en las cosas que ya se han hecho, en las que se están planeando/haciendo y en qué personas forman parte del proyecto. Las dos actividades esenciales son 2 ensayos clínicos en preparación. Uno es de seguridad/efectividad y el otro es de aceptabilidad/factibilidad/adherencia.
    • Lo digo porque igual según vayáis haciendo cambios se os ocurre

    • HOME

      • Background

      • Project

        • Proponemos 2 ensayos clínicos
          • Proposed safety and effectiveness study
            • Primary objective: evaluate and compare safety of the FDC against albendazole alone via MDA in two study areas in Kenya and Ghana
            • Secondary objectives:
            • Primary goal: Safety (incidence of SAEs)
            • Secondary goals:
              • Effectiveness at 21 days and 1 year
              • Genomic resistance
            • Sample size: around 20k
            • Target population: School based
            • Epidemiologic conditions on the sites: T. trichiura ongoing transmission areas
            • Countries: Ghana and Kenya
          • Proposed acceptability and feasiblity study
            • Primary goal: Acceptability and feasibility of the FDC
            • Secondary goals:
              • Adherence (3-day regimen)
              • Fidelity
        • Nuestros objetivos:
          • Overall goal: Support the achievement of the WHO 2030 NTD Roadmap for STH and beyond
          • Project purpose: Advance and accelerate an innovative pharmacological tool to support the elimination goals against STH species, especially those poorly responsive to current treatment regimens

      • Consortium

        • Hay que poner nombres. De primeras los miembros del steering commitee. Voy a proponer enlace a researchgate o Google Scholar.