Delivery of Malaria Chemoprevention in the Post-discharge Management of Children With Severe Anaemia in Malawi

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Background and rationale: Children hospitalised with severe anaemia in Africa are at high risk of readmission or death within 6 months after discharge. No strategy specifically addresses this post-discharge period. In Malawi, 3 months of post-discharge malaria chemoprevention (PMC) with monthly 3-day treatment courses of artemether-lumefantrine (AL) in children with severe malarial anaemia prevented 31% of deaths and readmissions. The effect was in addition to the effect of insecticide-treated bednets. There is now need to design and evaluate effective delivery mechanism for PMC within the health system.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Malawi College of Medicine
• Collaborators: Imperial College London; Kenya Medical Research Institute; Liverpool School of Tropical Medicine; London School of Hygiene and Tropical Medicine; Makerere University; Ministry of Health and Population, Malawi; Ministry of Health, Malawi; The Research Council of Norway; Universiteit van Amsterdam; University of Amsterdam; University of Bergen; University of Minnesota; University of Minnesota, MN
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Piperaquine

Criteria

Inclusion Criteria:

1. Haemoglobin <5.0g/dl or PCV <15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital

2. Age between 4 months (inclusive) and 59 months (inclusive)

3. Body weight >5kgs

Screening (in-hospital):

1. Fulfilled the pre-study screening eligibility criteria

2. Clinically stable, able to switch to oral medication

3. Subject completed blood transfusion(s) in accordance with routine hospital practice

4. Able to feed (for breastfed children) or eat (for older children)

5. Absence of known cardiac problems

6. Provision of informed consent by parent or guardian

Randomization (at discharge):

1. Fulfilled screening eligibility criteria

2. Still clinically stable, able to take oral medication, able to feed (for breastfed children) or eat (for older children) and able to sit unaided (for older children who were able to do so prior to hospitalization

Exclusion Criteria:

1. Recognised specific other cause of severe anaemia (e.g. trauma, haematological malignancy, known bleeding disorder)

2. Known sickle cell

3. Child will reside for more than 25% of the 3.5months study period (i.e. 3 weeks or more) outside of catchment area Enrolment in the study (t=0) at discharge

4. Previous enrolment in the present study

5. Known hypersensitivity to study drug

6. Sickle cell disease

7. Known need at the time of enrolment for concomitant prohibited medication during the 14 weeks PMC treatment period.

8. On-going or planned participation into another clinical trial involving on-going or scheduled treatment with medicinal products during the course of the study (3.5 months from enrolment)

9. Known need, or scheduled surgery during the course of the study (3.5 months)

10. Suspected non-compliance with the follow-up schedule

11. Known heart conditions, or family history of congenital prolongation of the QTc interval