6.4 KiB
- STOP2030/Web/Update 2024/02
-
Cambios 2024/02
- 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
- Proposed safety and effectiveness study
-
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
- 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
-
-