Post-discharge malaria prevention for children in Benin

Delivery Strategies for Malaria Chemoprevention in the Post-discharge Management of Children Hospitalised With Severe Anaemia or Severe Malaria: a Cluster Randomised Controlled Implementation Trial in Benin

This project will test different ways of giving three monthly, three-day antimalarial courses to children recovering from severe malaria or severe anaemia to see if caregivers give the medicines more reliably.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 648 (estimated)
• Ages: N/A to 9 Years
• Sex: All
• Sponsor: Institut de Recherche Clinique du Benin (other)
• Locations: 2 sites (Abomey and 1 other locations)
• Trial ID: NCT06601712 on ClinicalTrials.gov

What this trial studies

This is an implementation trial co-designed with national stakeholders in Benin comparing two adherence support strategies against standard care for post-discharge malaria chemoprevention (PDMC). Children under 10 who are discharged after hospitalization for severe malaria or severe anaemia will receive a monthly three-day antimalarial regimen for three months and be randomized to adherence support strategy A, strategy B, or control. The study will measure adherence to the dosing regimen, acceptability, feasibility, and cost-effectiveness, with secondary monitoring of readmissions and deaths in the months after discharge. Results are intended to guide national decisions on effective delivery and scale-up of PDMC in high-transmission settings.

Who should consider this trial

Good fit: Ideal participants are children under 10 years old being discharged after hospitalization for severe malaria or severe anaemia whose caregivers agree to follow-up at the participating hospitals.

Not a fit: Children with recognised non-malarial causes of severe anaemia (such as trauma or haematological malignancy), those with sickle cell disease, or infants weighing under 5 kg are excluded and unlikely to benefit from PDMC in this trial.

Why it matters

Potential benefit: If successful, the approaches could increase caregiver adherence to PDMC, reduce post-discharge malaria readmissions and deaths, and support wider national scale-up.

How similar studies have performed: Previous trials in East Africa showed PDMC reduces readmissions and deaths and WHO recommends PDMC, but the best delivery and adherence strategies remain untested in this context.

Eligibility criteria

Inclusion Criteria:

* Aged below 10 years of both sexes
* Hospitalised with severe anaemia or severe malaria: Initially hospitalised with haemoglobin below 5.0 g/dl or PCV below 15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital, or severe malaria, defined as a requirement for parenteral artesunate in the opinion of the treating clinician and the presence of microscopy or RDT confirmed Plasmodium infection

Exclusion Criteria:

* Recognised specific other causes of severe anaemia (i.e., trauma, haematological malignancy, known bleeding disorders, such as haemophilia)
* Sickle cell anaemia/sickle cell disease
* Body weight below 5 kg
* HIV infection and cotrimoxazole prophylaxis are not exclusion criteria

Where this trial is running

Abomey and 1 other locations

• Goho Departmental Hospital Centre — Abomey, Benin (NOT_YET_RECRUITING)
• Centre Hospitalier Universitaire de la Mere et de l'Enfant Lagune (CHU-MEL) — Cotonou, Benin (RECRUITING)

Study contacts

• Principal investigator: Jenny Hill, MSc, PhD — Liverpool School of Tropical Medicine
• Study coordinator: Manfred Accrombessi, MD, PhD

Conditions: Severe Malaria, Severe Anaemia, Children, Antimalarial, Prevention, Chemoprevention, Caregivers, Patient discharge