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Post-discharge Malaria Chemoprevention Implementation Trial in Benin ( PDMC-SL)

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
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202411682724094
Enrollment
648
Registered
2024-11-05
Start date
2024-11-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria Severe anaemia and severe malaria Paediatrics

Interventions

Delivery strategy A
Delivery strategy B
Delivery strategy control

Sponsors

Institut de Recherche Clinique du Benin
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.;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.;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.;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.;Cost per Disability adjusted life years (DALY) averted for each intervention versus control arm DALYs will be determined at the individual level and calculated based on the standard method used by the 2010 Global Burden of Disease Study (and using disability weights and life expectancies at age of death from the most recent WHO life tables). The total number of DALYs will be calculated by adding the DALYs for each individual who receives the intervention/s. The cost per DALY averted for each intervention will be compared against published country-specific willingness-to-pay thresholds to assess cost-effectiveness;Stakeholder perceptions of the feasibility on the delivery strategy with adherence supports Health

Countries

Benin

Contacts

Public ContactAchille Massougbodji

Director IRCB

massougbodjiachille@yahoo.fr+22996807027

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026