Abstract
(Englisch)
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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, noninferioritystudy 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.
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