The Cytoadherence in Pediatric Malaria (CPM) Study

Plasmodium Falciparum Malaria Clinical Trial

— CPM  

Official title:

Clinical Outcomes in Pediatric Plasmodium Falciparum Malaria According to Host Cytoadherence Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707200
• Other study ID #: 07-0548-AE
• Secondary ID: HS 356ISBT 77753
• Status: Completed
• Phase: N/A
• First received: June 26, 2008
• Last updated: January 22, 2010
• Start date: October 2007
• Est. completion date: November 2009

Study information

• Verified date: July 2009
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeUganda: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 12 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Plasmodium falciparum malaria infection

Exclusion Criteria:

• HIV or significant malnutrition

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Plasmodium Falciparum Malaria

Locations

Country	Name	City	State
Uganda	Mulago Hospital Acute Care Unit & Makerere University Department of Paediatrics & Child Health	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	University of Toronto

Country where clinical trial is conducted

Uganda, 

References & Publications (2)

Cserti CM, Dzik WH. The ABO blood group system and Plasmodium falciparum malaria. Blood. 2007 Oct 1;110(7):2250-8. Epub 2007 May 14. Review. — View Citation

Cserti-Gazdewich CM, Dzik WH, Dorn ME, Quagliaroli RO, Xu S, Ssewanyana I, Nayyar R, Preffer FI. Quantitation of CD36 (platelet glycoprotein IV) expression on platelets and monocytes by flow cytometry: application to the study of Plasmodium falciparum mal — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined severe morbidity & mortality		Discharge	No
Secondary	Laboratory indices of potential cytoadhesion (lactate, cell counts)		Presentation	No

External Links

•   CPM Study's official website