PDMC Implementation Trial in Kenya
Recruiting now · Phase 4
Conditions studied: Severe Malaria, Severe Anemia
In brief
The goal of this implementation trial is to evaluate at least two alternative delivery strategies and adherence support for malaria chemoprevention with dihydroartemisinin-piperaquine in the post-discharge management of children hospitalised with severe anaemia or severe malaria to optimise adherence in Kenya. The actual interventions to be evaluated have been co-designed with national stakeholders during an initial formative research stage.
Key facts
- Study ID
- NCT06624631
- Run by
- Liverpool School of Tropical Medicine
- People needed
- 600
- Starts
- 2025-09-05
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2025-11-21
Who can join
Age: any, up to 9. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- CLUSTERS
- Health facilities with blood transfusion services offering in-patient care for children with severe anaemia and severe malaria.
- >=40 children per year admitted with severe anaemia or severe malaria
- Agreement to participate by facility management
- Located in areas with moderate to high malaria transmission
- INDIVIDUAL PARTICIPANTS
- Aged <10 years of both sexes
- Hospitalised with severe anaemia or severe malaria: Initially hospitalised with haemoglobin <5.0 g/dl or PCV <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/or the presence of microscopy or RDT confirmed Plasmodium infection
You may not qualify if…
- CLUSTERS
- Health facilities without subservient lower-level health facilities
- INDIVIDUAL PARTICIPANTS
- 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 <5 kg
- HIV infection and cotrimoxazole prophylaxis are not exclusion criteria.
Where it is running
- Kemri, Cghr — Kisumu, Kenya (enrolling)
Full record on ClinicalTrials.gov
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