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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Maximum Age: 9
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Benin
Goho Departmental Hospital Centre
NOT_YET_RECRUITING
Abomey
Centre Hospitalier Universitaire de la Mere et de l'Enfant Lagune (CHU-MEL)
RECRUITING
Cotonou
Contact Information
Primary
Manfred Accrombessi, MD, PhD
accrombessimanfred@gmail.com
22966033138
Backup
Achille Massougbodji, MD
massougbodjiachille@yahoo.fr
22996807027
Time Frame
Start Date: 2025-07-02
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 648
Treatments
Experimental: Arm A
All PDMC drugs will be given to the caregivers at discharge with reminder support
Experimental: Arm B
All PDMC drugs will be given by the community health workers (CHWs) to the caregivers at home, with reminder support
Active_comparator: Arm C
All PDMC drugs will be given to the caregivers at discharge with no other adherence support approaches (no reminder)
Related Therapeutic Areas
Sponsors
Collaborators: Centres for Disease Control and Prevention, Kenya., Kenya Medical Research Institute, Training Research Unit of Excellence, Blantyre, Malawia, Epicentre, Paris, France and Mbarara University of Science and Technology, Faculty of Medicine, Mbarara, Uganda, Liverpool School of Tropical Medicine, Institut de Recherche pour le Developpement
Leads: Institut de Recherche Clinique du Benin

This content was sourced from clinicaltrials.gov