NCT06601712 Post-discharge Malaria Chemoprevention Implementation Trial in Benin
| NCT ID | NCT06601712 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Institut de Recherche Clinique du Benin |
| Condition | Severe Malaria |
| Study Type | INTERVENTIONAL |
| Enrollment | 648 participants |
| Start Date | 2025-07-02 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 648 participants in total. It began in 2025-07-02 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The proposed research aims to conduct implementation trials in Benin, co-designed with national stakeholders, to evaluate different delivery strategies for optimizing health system delivery of post-discharge malaria chemoprevention (PDMC) drugs and adherence to PDMC. This chemoprevention strategy is effective in reducing hospital readmissions and deaths after discharge. However, there is no clear delivery platform for PDMC, and adherence to the 3-day dosing regimen, provided monthly three times after discharge, is a potential limitation. The current trial will provide evidence-based data on acceptability, feasibility, and cost-effectiveness to aid decision-makers. The evidence generated will be used to support the effective implementation and scale-up of PDMC in high malaria-endemic areas such as Benin.
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
Contact & Investigator
Jenny Hill, MSc, PhD
PRINCIPAL INVESTIGATOR
Liverpool School of Tropical Medicine
Frequently Asked Questions
Who can join the NCT06601712 clinical trial?
This trial is open to participants of all sexes, up to 9 Years, studying Severe Malaria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06601712 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06601712 currently recruiting?
Yes, NCT06601712 is actively recruiting participants. Contact the research team at accrombessimanfred@gmail.com for enrollment information.
Where is the NCT06601712 trial being conducted?
This trial is being conducted at Abomey, Benin, Cotonou, Benin.
Who is sponsoring the NCT06601712 clinical trial?
NCT06601712 is sponsored by Institut de Recherche Clinique du Benin. The principal investigator is Jenny Hill, MSc, PhD at Liverpool School of Tropical Medicine. The trial plans to enroll 648 participants.