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The Cytoadherence in Pediatric Malaria (CPM) Study (CPM)

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ClinicalTrials.gov Identifier: NCT00707200
Recruitment Status : Completed
First Posted : June 30, 2008
Last Update Posted : January 26, 2010
Sponsor:
Collaborator:
University of Toronto
Information provided by:
University Health Network, Toronto

Brief Summary:
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 or disease
Plasmodium Falciparum Malaria

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Outcomes in Pediatric Plasmodium Falciparum Malaria According to Host Cytoadherence Factors
Study Start Date : October 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Group/Cohort
1
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.
2
Controls: Controls consist of mildly-affected children with P falciparum malaria who are either managed as inpatients or outpatients.



Primary Outcome Measures :
  1. Combined severe morbidity & mortality [ Time Frame: Discharge ]

Secondary Outcome Measures :
  1. Laboratory indices of potential cytoadhesion (lactate, cell counts) [ Time Frame: Presentation ]

Biospecimen Retention:   Samples With DNA
Freshly frozen citrated plasma aliquots, frozen spun red cell pellets, and whole blood blots onto nucleic acid storage cards (Whatman FTA).


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children, age 6 months to 12 years, with symptomatic malaria and (asexual) Plasmodium falciparum parasitemia.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Plasmodium falciparum malaria infection

Exclusion Criteria:

  • HIV or significant malnutrition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707200


Locations
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Uganda
Mulago Hospital Acute Care Unit & Makerere University Department of Paediatrics & Child Health
Kampala, Uganda
Sponsors and Collaborators
University Health Network, Toronto
University of Toronto
Investigators
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Study Director: Nicolette Nabukeera-Barungi, MBChB, MMEd Mulago Hospital/Makerere University (lead local investigator)

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christine Cserti-Gazdewich, University Health Network
ClinicalTrials.gov Identifier: NCT00707200     History of Changes
Other Study ID Numbers: 07-0548-AE
HS 356
ISBT 777531237
First Posted: June 30, 2008    Key Record Dates
Last Update Posted: January 26, 2010
Last Verified: July 2009

Keywords provided by University Health Network, Toronto:
severe malarial anemia (SMA)
cerebral malarial (CM)
lactic acidosis
hyperparasitemia
respiratory distress
hypoxia
death
transfusion

Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases