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Search / Trial NCT06624631

PDMC Implementation Trial in Kenya

Launched by LIVERPOOL SCHOOL OF TROPICAL MEDICINE · Oct 1, 2024

Trial Information

Current as of April 29, 2025

Not yet recruiting

Keywords

Children Antimalarial Prevention Chemoprevention Caregivers Patient Discharge Healthcare Providers Health Economics Qualitative Research Feasibility Cost Effectiveness Kenya Artemisinins School Age Pre School

ClinConnect Summary

The PDMC Implementation Trial in Kenya is a study designed to find the best ways to help children recover from severe malaria and severe anemia after they leave the hospital. Researchers will explore different methods to provide medication called dihydroartemisinin-piperaquine, which helps prevent malaria, and they will work with local health experts to create these strategies. The ultimate goal is to ensure that children continue to take their medicine after being discharged from the hospital.

To participate in this trial, children must be under 10 years old and have been hospitalized with severe anemia (very low blood levels) or severe malaria (a serious illness caused by a mosquito-borne parasite). Hospitals that are part of the study need to treat at least 40 children with these conditions each year. Participants will receive support to help them take their medication as prescribed. It's important to note that children with certain other medical issues, like specific blood disorders, will not be eligible for the trial. This study is currently not recruiting participants, but it aims to improve care for children affected by these serious health conditions in Kenya.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 the presence of microscopy or RDT confirmed Plasmodium infection
  • Exclusion Criteria:
  • 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.

About Liverpool School Of Tropical Medicine

The Liverpool School of Tropical Medicine (LSTM) is a leading institution dedicated to research and education in tropical medicine and global health. Established in 1898, LSTM focuses on addressing health challenges faced by populations in low- and middle-income countries through innovative research, capacity building, and policy advocacy. As a clinical trial sponsor, LSTM is committed to conducting rigorous and ethical trials aimed at improving health outcomes, developing effective interventions, and advancing scientific knowledge in tropical diseases. The institution collaborates with a network of global partners to ensure the successful translation of research findings into practical solutions for public health challenges.

Locations

Patients applied

0 patients applied

Trial Officials

Feiko ter Kuile, MD, PhD

Principal Investigator

LSTM

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported