Periodic Reporting for period 1 - EChiLiBRiST (Development and validation of a quantitative point-of-care test for the measurement of severity biomarkers to improve risk stratification of fever syndromes and enhance child survival)
Periodo di rendicontazione: 2022-09-01 al 2024-02-29
ISGlobal-led Consortium Launches Project to Reduce Child Mortality by Exploring a New Tool for the Risk-Stratification of Children with Fever
The EU-funded Project EChiLiBRiST will develop and trial a rapid test for the early recognition and management of febrile patients at risk of severe disease
Fever is a cardinal signal of infectious diseases and over one billion episodes are recorded every year globally. On average, a child under 5 years of age in sub-Saharan Africa (SSA), experiences up to 6 episodes of fever annually. Though most episodes are mild and self-limiting, some can progress to life-threatening disease. In SSA, 50% of the fever-related deaths among children occur at the community level, without access to formal healthcare.
EChiLiBRiST – Enhancing Children’s Lives with Biomarkers for Risk Stratification and Triage, is a consortium of 13 institutions from Europe, the United Kingdom, Africa and Canada convened to develop and clinically validate a quantitative point-of-care test for the measurement of severity biomarkers to improve risk stratification of fever syndromes and thus, enhance child survival. This 5-year project is funded by the European Union’s Horizon Europe research and innovation programme.
The project consists of two distinct yet complementary workstreams – 1) Design and validation of the device and establishing the exploitation and regulatory pathways; 2) Clinical trials and sub-studies in 3 African countries to assess the impact of the introduction of the device for risk stratification purposes, to enhance outcomes, guide management, and save costs.
“Fever is an excellent warning system for clinicians, but it is often challenging to differentiate those fevers caused by life-threatening infections from those caused from self-limited and benign conditions. With the EChiLiBRiST project, we aim to measure severity biomarkers at the patient’s bedside, with the hope to transform fever management globally. With a more targeted focus on those that really require prioritization, we can reduce death, disability, and health care costs,” explains Quique Bassat, the Principal Investigator of the project.
“The technology behind the device is based on magnetic particles for the preconcentration of the biomarkers to achieve high sensitivity, a mandatory feature of such a risk stratification tool. We will use a rapid and quantitative detection method, so that in 10 minutes, the clinicians can use the levels of these severity biomarkers to make clinical decisions. It will also be user-friendly and battery-powered, allowing its implementation at the point of care”, explains Isabel Pividori, the Investigator leading the development of the device and group leader at IBB-UAB.
Beyond the clinical and technological rigour of the study design, there are other notable aspects including its interdisciplinary approach to ensure that the new product is compatible for use in low-income settings, and that the data generated can be useful to model and predict impact and cost-saving in different scenarios. Additionally, the project has also committed to train 3 African graduates from the participating countries (Mozambique, Ethiopia and Gabon) with different disciplinary backgrounds to obtain a PhD.
“Building a common pathway from diagnosis to treatment is of utmost importance, especially in the African context with irregular access to health services,” says Bàrbara Baro, Scientific Coordinator of the project. “EChiLiBRiST holds the potential to reverse child mortality trends from commonly treatable diseases in low-income countries.”
The EU-funded Project EChiLiBRiST will develop and trial a rapid test for the early recognition and management of febrile patients at risk of severe disease
Fever is a cardinal signal of infectious diseases and over one billion episodes are recorded every year globally. On average, a child under 5 years of age in sub-Saharan Africa (SSA), experiences up to 6 episodes of fever annually. Though most episodes are mild and self-limiting, some can progress to life-threatening disease. In SSA, 50% of the fever-related deaths among children occur at the community level, without access to formal healthcare.
EChiLiBRiST – Enhancing Children’s Lives with Biomarkers for Risk Stratification and Triage, is a consortium of 13 institutions from Europe, the United Kingdom, Africa and Canada convened to develop and clinically validate a quantitative point-of-care test for the measurement of severity biomarkers to improve risk stratification of fever syndromes and thus, enhance child survival. This 5-year project is funded by the European Union’s Horizon Europe research and innovation programme.
The project consists of two distinct yet complementary workstreams – 1) Design and validation of the device and establishing the exploitation and regulatory pathways; 2) Clinical trials and sub-studies in 3 African countries to assess the impact of the introduction of the device for risk stratification purposes, to enhance outcomes, guide management, and save costs.
“Fever is an excellent warning system for clinicians, but it is often challenging to differentiate those fevers caused by life-threatening infections from those caused from self-limited and benign conditions. With the EChiLiBRiST project, we aim to measure severity biomarkers at the patient’s bedside, with the hope to transform fever management globally. With a more targeted focus on those that really require prioritization, we can reduce death, disability, and health care costs,” explains Quique Bassat, the Principal Investigator of the project.
“The technology behind the device is based on magnetic particles for the preconcentration of the biomarkers to achieve high sensitivity, a mandatory feature of such a risk stratification tool. We will use a rapid and quantitative detection method, so that in 10 minutes, the clinicians can use the levels of these severity biomarkers to make clinical decisions. It will also be user-friendly and battery-powered, allowing its implementation at the point of care”, explains Isabel Pividori, the Investigator leading the development of the device and group leader at IBB-UAB.
Beyond the clinical and technological rigour of the study design, there are other notable aspects including its interdisciplinary approach to ensure that the new product is compatible for use in low-income settings, and that the data generated can be useful to model and predict impact and cost-saving in different scenarios. Additionally, the project has also committed to train 3 African graduates from the participating countries (Mozambique, Ethiopia and Gabon) with different disciplinary backgrounds to obtain a PhD.
“Building a common pathway from diagnosis to treatment is of utmost importance, especially in the African context with irregular access to health services,” says Bàrbara Baro, Scientific Coordinator of the project. “EChiLiBRiST holds the potential to reverse child mortality trends from commonly treatable diseases in low-income countries.”
During this first 18-months period the EChiLiBRiST consortium worked closely to accomplish the first established deliverables and advance towards the planned objectives.
This first period was mainly focus on the development of the laboratory prototype and its validation through the use of retrospectives samples, get the basis for the clinical trials with the preparation of the protocols and also work on the patentability and regulatory approval roadmaps of the device.
The work performed on this first period focused on workstream 1 as detailed below
Workstream 1: Design and validation of the device and establishing the exploitation and regulatory pathways
• Aim 1: To develop a laboratory prototype and determine its analytical performance against reference techniques. This work is currently in its final phase and led by BioEclosion and Eurecat. In particular Eurecat developed a specific own electrode to respond to the demand of the prototype which will allow us to reduce the final cost of the device.
• Aim 2: To retrospectively evaluate the clinical performance of the laboratory prototype with stored samples. This work in on-going and will help us fully validate the prototype and the comparator method that will be used during the clinical trials.
• Aim 3: To develop a functional prototype of the device and the production process of mini-series. This will be performed in the following months
• Aim 4: To develop an exploitation plan, including IP protection, FTO and commercialization paths assessment. Two Freedom To Operate (FTO) have been performed and we receive support from the EU Horizon Booster team to develop business plan for our Key Exploitable Results
• Aim 5: To establish a roadmap for regulatory approval of the device. Regulatory EU roadmap was done and patentability is in progress.
The work performed allowed us to prepare the implementation of the clinical and ancillary studies by defining the individual protocols and prepare the sites for its future implementation.
Workstream 2: Clinical trials and sub-studies to assess the impact of the introduction of the device for risk stratification purposes, to enhance outcomes, guide management, and save costs.
• Aim 6: To determine the performance of the PoC RTT in terms of appropriately supporting the need for admission (“appropriateness”) and compare it to standard of care triaging approaches (IMCI-based)
• Aim 7: To determine the effectiveness of L-citrulline supplementation in improving long-term outcomes among children risk-stratified by the PoC RTT and subsequently discharged
• Aim 8: To model the health impact of nationwide implementation of the device in low-income settings
• Aim 9: To assess the economic consequences of introducing the device in low-income settings.
• Aim 10: To assess the acceptance by health care providers and families of using the RTT for risk-stratification
This first period was mainly focus on the development of the laboratory prototype and its validation through the use of retrospectives samples, get the basis for the clinical trials with the preparation of the protocols and also work on the patentability and regulatory approval roadmaps of the device.
The work performed on this first period focused on workstream 1 as detailed below
Workstream 1: Design and validation of the device and establishing the exploitation and regulatory pathways
• Aim 1: To develop a laboratory prototype and determine its analytical performance against reference techniques. This work is currently in its final phase and led by BioEclosion and Eurecat. In particular Eurecat developed a specific own electrode to respond to the demand of the prototype which will allow us to reduce the final cost of the device.
• Aim 2: To retrospectively evaluate the clinical performance of the laboratory prototype with stored samples. This work in on-going and will help us fully validate the prototype and the comparator method that will be used during the clinical trials.
• Aim 3: To develop a functional prototype of the device and the production process of mini-series. This will be performed in the following months
• Aim 4: To develop an exploitation plan, including IP protection, FTO and commercialization paths assessment. Two Freedom To Operate (FTO) have been performed and we receive support from the EU Horizon Booster team to develop business plan for our Key Exploitable Results
• Aim 5: To establish a roadmap for regulatory approval of the device. Regulatory EU roadmap was done and patentability is in progress.
The work performed allowed us to prepare the implementation of the clinical and ancillary studies by defining the individual protocols and prepare the sites for its future implementation.
Workstream 2: Clinical trials and sub-studies to assess the impact of the introduction of the device for risk stratification purposes, to enhance outcomes, guide management, and save costs.
• Aim 6: To determine the performance of the PoC RTT in terms of appropriately supporting the need for admission (“appropriateness”) and compare it to standard of care triaging approaches (IMCI-based)
• Aim 7: To determine the effectiveness of L-citrulline supplementation in improving long-term outcomes among children risk-stratified by the PoC RTT and subsequently discharged
• Aim 8: To model the health impact of nationwide implementation of the device in low-income settings
• Aim 9: To assess the economic consequences of introducing the device in low-income settings.
• Aim 10: To assess the acceptance by health care providers and families of using the RTT for risk-stratification
The development of a laboratory prototype and determine its analytical performance against reference techniques is currently ongoing including the development of a specific own electrode to respond to the demand of the prototype which will allow us to reduce the final cost of the device.
The validation of the laboratory prototype with retrospective samples is currently ongoing and will help us fully validate the prototype and the comparative method that will be used during the clinical trials..
Two Freedom To Operate (FTO) have been performed and we receive support from the EU Horizon Booster team to develop business plan for our Key Exploitable Results.
All these elements will allow us to obtain in the following months a fully validated prototype to be passed to the functional status and start the planned clinical trials for evaluation.
The validation of the laboratory prototype with retrospective samples is currently ongoing and will help us fully validate the prototype and the comparative method that will be used during the clinical trials..
Two Freedom To Operate (FTO) have been performed and we receive support from the EU Horizon Booster team to develop business plan for our Key Exploitable Results.
All these elements will allow us to obtain in the following months a fully validated prototype to be passed to the functional status and start the planned clinical trials for evaluation.