Study of Factors Involved in Resistance to Severe Malaria (NCT00368810) | Clinical Trial Compass
CompletedNot Applicable
Study of Factors Involved in Resistance to Severe Malaria
United States120 participantsStarted 2006-02-21
Plain-language summary
This study will examine whether resistance to severe malaria is associated with weakening of a specific immune response (TLR-mediated pro-inflammatory cytokine response). Some children with mild malaria go on to develop severe disease, while others do not. The study will analyze certain substances in the blood to try to determine what factors may protect against severe malaria.
Healthy children and children 3 - 10 years of age with severe malaria who are being treated at l'H pital Gabriel Toure in Mamako, Mali, West Africa, may be eligible for this study. Participants have a mall sample of blood drawn from a vein and from two finger pricks.
Who can participate
Age range2 Years – 10 Years
SexALL
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Inclusion criteria
✓. Males or females ages 3 to 10.
✓. Severe malaria as defined by positive blood smear for P. falciparum and need for hospitalization in accordance with the WHO definition of severe malaria (group I), or mild malaria as defined by positive blood smear for P. falciparum and triage to outpatient treatment (group II).
✓. Willingness of parent or guardian to have his or her child participate in the study as evidenced by the completed informed consent document.
✓. Males or females ages 3 to 10.
✓. No clinical evidence of malaria and negative blood smear.
✓. No acute febrile or systemic illness.
✓. Willingness of parent or guardian to have his or her child participate in the study as evidenced by the completed informed consent document.
Exclusion criteria
✕. Active bleeding or hematocrit less than or equal to 15%.
✕. Participation in a vaccine or drug trial within 30 days of starting this study.
Trial details
NCT IDNCT00368810
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)