Post-discharge Malaria Chemoprevention Implementation Trial in Benin
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 9
SponsorInstitut de Recherche Clinique du Benin
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Adherence support strategy A
- Adherence support strategy B
- Control
Treatment groups
648 Participants
are divided into 3 treatment groupsSponsors and collaborators
Institut de Recherche Clinique du Benin
Lead sponsor
Liverpool School of Tropical Medicine
Collaborator
Kenya Medical Research Institute
Collaborator
Epicentre, Paris, France and Mbarara University of Science and Technology, Faculty of Medicine, Mbarara, Uganda
Collaborator
Institut de Recherche pour le Developpement
Collaborator
Training Research Unit of Excellence, Blantyre, Malawia
Collaborator
Centres for Disease Control and Prevention, Kenya.
Collaborator
Source ClinicalTrials.gov