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Recruiting
NCT06601712
Post-discharge Malaria Chemoprevention Implementation Trial in Benin
Conditions: Severe Malaria, Severe Anaemia
Sex: All
Ages: N/A – 9 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 648
Sponsor: Institut de Recherche Clinique du Benin
Location: Goho Departmental Hospital Centre Abomey
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
Source: ClinicalTrials.gov (NCT06601712). StuddyBuddy aggregates publicly available trial information.