Clinical and Translational Investigations of Severe Malaria Pathophysiology [Parent Study Protocol]
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Open-label randomized controlled trial to test the effectiveness of whole blood transfusion for improving survival in children with severe malaria complicated by thrombocytopenia.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 4
Healthy Volunteers: f
View:
• Age \<5 years
• Platelet count ≤75,000/uL
• Hemoglobin \>5 and ≤9 g/dL
• P. falciparum parasitemia ≥500 parasites/uL
• Diagnosis of severe malaria meeting World Health Organization (WHO) criteria
• Ability and willingness of the legal guardian to comply with study protocol for the duration of the study
• Residence within health clinic catchment area
• Signed informed consent obtained from the parent or legal guardian of the participant
Locations
United States
Maryland
Johns Hopkins Bloomberg School of Public Health
NOT_YET_RECRUITING
Baltimore
Other Locations
Zambia
Tropical Diseases Research Centre
RECRUITING
Ndola
Contact Information
Primary
Matthew M Ippolito, MD PhD
mippolito@jhu.edu
443-287-4809
Time Frame
Start Date: 2024-02-24
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 132
Treatments
Experimental: Whole blood transfusion
Whole blood transfusion x1 (20 mL/kg)
No_intervention: Control
Standard-of-care
Related Therapeutic Areas
Sponsors
Collaborators: Tropical Diseases Research Centre, University of Maryland, Johns Hopkins University, University of California, San Francisco
Leads: Johns Hopkins Bloomberg School of Public Health