Clinical trial Recruiting at 1 site Phase 4 Interventional Ages Any age to 9

Post-discharge malaria prevention for children in Benin

Official title: 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

Run by Institut de Recherche Clinique du Benin · NCT06601712 · Data updated 2026-11-12

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.

More Severe Malaria trials

Quick facts

PhasePhase 4
Study typeInterventional
AgesAny age to 9 Years
SexAll
Enrollment648 (estimated)
SponsorInstitut de Recherche Clinique du Benin
Academic / other
Locations2 sites (Abomey and 1 other locations)
StatusRecruiting
StartedJuly 2, 2025
Main results expectedNovember 30, 2026
Study endsDecember 31, 2026
Registry record updatedAugust 12, 2026
Trial IDNCT06601712 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Centre Hospitalier Universitaire de la Mere et de l'Enfant Lagune (CHU-MEL)
    Cotonou, Benin
    Recruiting
  • Goho Departmental Hospital Centre
    Abomey, Benin
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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    This study is testing if giving whole blood transfusions can help children aged 6 months to 15 years with severe malaria live longer compared to standard care without transfusions.

    Recruiting Johns Hopkins Bloomberg School of Public Health · Baltimore, Maryland and 1 other locations · NCT05711485

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.