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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Adherence support strategy A
Other interventionCommunity health worker (CHW) support through monthly home visits to remind the caregiver to administrate the PDMC drugs
Adherence support strategy B
Other interventionSMS/phone reminders from the qualified community health officers (ASCQ) to the community health workers (CHW) to administrate the PDMC drugs
Control
Other interventionNo reminders
Treatment groups
648 Participants
are divided into 3 treatment groupsGroup A: Arm AExperimental treatment 1 intervention
Group B: Arm BExperimental treatment 1 intervention
Group C: Arm CActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of children with incomplete adherence to 9 doses of PDMC by the end of week 14 post-discharge
Adherence to the PDMC strategy: Proportion of children with incomplete adherence to 9 doses of PDMC (three courses of 3-day treatments 3x3=9) i.e. the number of children who do not receive the total of 9 doses of PDMC tablets by the end of week 14 after discharge out of the total sample size.
Time frame
Administration of PDMC courses at 2, 6 and 10 weeks post dischargeSecondary outcomes
1
Number of children readmitted to hospital from all-cause and malaria-specific by the end of week 14 post-discharge
Incidence of all-cause and malaria-specific readmissions by the end of week 14 after discharge, i.e. the number of children readmitted for malaria by the end of week 14 after discharge out of the total sample size.
Time frame
14 weeks post discharge2
Number of sick-child clinic visits from all-cause and malaria-specific by the end of week 14 post-discharge
Proportion of all-cause and malaria-specific sick-child clinic visits by the end of week 14 after discharge, i.e. the number of children who visit the hospital for any cause or due to malaria by the end of week 14 after discharge out of the total of sample size
Time frame
14 weeks post discharge3
Number of children who die within 14 weeks post-discharge
Incidence of all-cause mortality of children by the end of week 14 after discharge, i.e. the number of children who die within 14 weeks of discharge out of the total sample size
Time frame
14 weeks post discharge4
Number of serious adverse events following PDMC administration within 14 weeks post-discharge
Safety of PDMC strategy: Proportion of serious adverse events occurring after discharge to 14 weeks post-discharge, i.e. the number of children presenting serious adverse events by the end of week 14 after discharge out of the total sample size
Time frame
14 weeks post dischargeSponsors and contacts
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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