An observational study in Plasmodium Falciparum Malaria, sponsored by University Health Network, Toronto. Completed at 1 site in Uganda. Open to participants aged 6 Months to 12 Years. Per ClinicalTrials.gov, last updated 2010-01-26.
Sponsored by University Health Network, Toronto · Observational
The purpose of this study is to determine the importance of key blood group molecules in the clinical outcome of Plasmodium falciparum malaria infection in children.
Every year, nearly 2 million children die from infection with Plasmodium falciparum malaria. When red blood cells (RBC) become infected with malaria, a sticky parasite-derived knob protein, termed PfEMP-1, erupts on the RBC surfaces. PfEMP-1 attaches to several blood group molecules, including those found on other RBC, on blood vessels, and on the cells that normally help to stop bleeding (platelets). The cellular sticking results in a dangerous interruption in blood flow to vital organs, causing brain injury (cerebral malaria), systemic shock (lactic acidosis), and death. Depending on an individual's inherited blood groups of relevance, adhesion may be extensive or limited. In the laboratory, PfEMP-1 adheres to RBCs via the A or B (but not the O) antigens of the ABO blood group system, and to platelets and blood vessels via platelet glycoprotein IV (CD36) and ICAM-1. Consistent with the expected evolutionary advantage of being deficient in these binding targets, blood type O and low-expression of CD36 are found more frequently among Africans. The "Cytoadherence in Pediatric Malaria" (CPM) project is determining the distribution of adhesive blood group molecules in a cohort of 2000 Ugandan children according to the extent of malaria severity and death, and thus their ultimate clinical and evolutionary significance in malarial survival. This knowledge may serve as the grounds for developing targeted cytoadhesion-interruption therapies in our fight against malaria.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 600 across 218 observational studies indexed under Malaria.
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Children, age 6 months to 12 years, with symptomatic malaria and (asexual) Plasmodium falciparum parasitemia.
Exclusion Criteria:
Cases: Severe inpatient malaria, survivors or decedents. Severe malaria consists of any one or combination of severe malarial anemia (SMA), cerebral malaria (CM), lactic acidosis (LA), or a respiratory distress syndrome with hypoxia.
Controls: Controls consist of mildly-affected children with P falciparum malaria who are either managed as inpatients or outpatients.
Combined severe morbidity & mortality
Time frame: Discharge
Laboratory indices of potential cytoadhesion (lactate, cell counts)
Time frame: Presentation
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto