Description du projet
Développer des politiques durables de traitement du paludisme grave par administration rectale d’artésunate
Le paludisme tue chaque année près de 500 000 enfants âgés de moins de cinq ans en Afrique. L’OMS recommande l’administration préalable d’artésunate par voie rectale (RAS), suivie d’artésunate injectable et d’une thérapie combinée à base d’artémisinine, ce schéma réduisant la létalité de 96 %. L’efficacité clinique et l’impact au niveau de la population sont incertains en raison du manque de données relatives aux résultats. Le déploiement du RAS reste donc limité. Le projet SEMA ReACT, financé par l’UE, est une étude d’observation de sa mise en œuvre en Zambie et en République démocratique du Congo. Ses agents de santé communautaires sont chargés d’identifier, diagnostiquer, traiter et suivre les patients atteints de paludisme grave dans le cadre d’une gestion intégrée des cas au niveau communautaire. Le projet en évaluera l’impact au niveau de la population. Il comparera également les algorithmes de traitement dans les zones reculées et recommandera des politiques durables.
Objectif
Annually, almost 500,000 children under 5 years die from malaria in Africa. Timely access to effective antimalarial therapies is life saving as treatment with pre-referral rectal artesunate (RAS), followed by injectable artesunate and 3 days treatment with ACTs leads to an observed 96% reduction in mortality. Though recommended by the WHO for years, RAS deployment is very limited.
The full treatment paradigm is not always feasible when access to primary healthcare facilities is limited due to lack of transport, non-availability of services, and cost. Rollout has recently been paused as outcomes data is incomplete in these contexts making the development of best practice recommendations challenging. Hence the relevance of the proposed study.
The proposed project is an observational, non-inferiority study in Zambia and DRC. Community Health Care Workers will identify/diagnose, treat and follow up patients with (severe) malaria as part of integrated community case management. We will compare the efficacy of a treatment regimen consisting of pre-referral RAS, then post-referral injectable artesunate, followed by three days of ACT versus a regimen consisting of RAS alone followed by three days of ACT in remote areas. We will compare recurrence rate between the two regimens at Day 28, the number of lives saved, the risk of generating drug resistance. We will assess and mitigate operational and institutional facilitators and barriers in all stakeholders (patients, caregivers, health care providers, regulators, malaria experts) and recommend sustainable policies for this remote context. This generated evidence will support policy development and implementation.
The proposed consortium brings together vital experience in the rollout and deployment of rectal artesunate, study design and execution, social science, data collection and management, stakeholder engagement and translation of research results into clinical practice.
Champ scientifique
Mots‑clés
Programme(s)
- HORIZON.2.1 - Health Main Programme
Régime de financement
HORIZON-JU-RIA - HORIZON JU Research and Innovation ActionsCoordinateur
2000 Antwerpen
Belgique