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Sponsors and Collaborators: |
University Health Network, Toronto University of Toronto |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00707200 |
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.
Condition |
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Plasmodium Falciparum Malaria |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Clinical Outcomes in Pediatric Plasmodium Falciparum Malaria According to Host Cytoadherence Factors |
Freshly frozen citrated plasma aliquots, frozen spun red cell pellets, and whole blood blots onto nucleic acid storage cards (Whatman FTA).
Estimated Enrollment: | 2000 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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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.
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Controls: Controls consist of mildly-affected children with P falciparum malaria who are either managed as inpatients or outpatients.
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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.
Ages Eligible for Study: | 6 Months to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Children, age 6 months to 12 years, with symptomatic malaria and (asexual) Plasmodium falciparum parasitemia.
Inclusion Criteria:
Exclusion Criteria:
Contact: Christine M Cserti-Gazdewich, MD, FRCPC | 416-340-4800 ext 6303 | Christine.Cserti@uhn.on.ca |
Contact: Walter (Sunny) H Dzik, MD | 617-726-3715 | sdzik@partners.org |
Uganda | |
Mulago Hospital Acute Care Unit & Makerere University Department of Paediatrics & Child Health | Recruiting |
Kampala, Uganda | |
Sub-Investigator: Aggrey Dhabangi, MBChB | |
Sub-Investigator: Charles Musoke, MBChB | |
Sub-Investigator: Arthur Mpimbaza, MBChB, MMEd | |
Sub-Investigator: Henry Ddungu, MBChB, MMEd | |
Sub-Investigator: Isaac Ssewanyana, BS |
Study Director: | Nicolette Nabukeera-Barungi, MBChB, MMEd | Mulago Hospital/Makerere University (lead local investigator) |
Responsible Party: | University Health Network ( Christine Cserti-Gazdewich ) |
Study ID Numbers: | 07-0548-AE, HS 356, ISBT 777531237 |
Study First Received: | June 26, 2008 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00707200 |
Health Authority: | Canada: Ethics Review Committee; Uganda: Research Ethics Committee |
severe malarial anemia (SMA) cerebral malarial (CM) lactic acidosis hyperparasitemia |
respiratory distress hypoxia death transfusion |
Protozoan Infections Death Acidosis, Lactic Anemia |
Parasitic Diseases Malaria Acidosis Malaria, Falciparum |
Coccidiosis |