Study of Factors Involved in Resistance to Severe Malaria

NCT00368810 | Completed

• 2 other identifiers: 99990610406-I-N104
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malaria

Keywords

Children; Cross-Sectional; Glycosylphosphatidylinositol; Cytokines; Peripheral Blood Mononuclear Cells; Malaria

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Active bleeding or hematocrit less than or equal to 15%.
• Participation in a vaccine or drug trial within 30 days of starting this study.
• Use of corticosteroids or immunosuppressive drugs within 30 days of starting this study.
• Receipt of a live vaccine within past 4 weeks or killed vaccine within past 2 weeks prior to entry into the study.
• Known history of HIV infection.
• Positive malaria smear.
• Sibling of malaria patient.
• Active bleeding or hematocrit less than or equal to 15%.
• Participation in a vaccine or drug trial within 30 days of starting this study.
• Use of corticosteroids or immunosuppressive drugs within 30 days of starting this study.
• Receipt of a live vaccine within past 4 weeks or killed vaccine within past 2 weeks prior to entry into the study.
• Known history of HIV infection.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Boutlis CS, Gowda DC, Naik RS, Maguire GP, Mgone CS, Bockarie MJ, Lagog M, Ibam E, Lorry K, Anstey NM. Antibodies to Plasmodium falciparum glycosylphosphatidylinositols: inverse association with tolerance of parasitemia in Papua New Guinean children and adults. Infect Immun. 2002 Sep;70(9):5052-7. doi: 10.1128/IAI.70.9.5052-5057.2002.

  PMID: 12183552 BACKGROUND

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 22, 2006
• First Posted: August 25, 2006
• Study Start: February 21, 2006
• Study Completion: November 30, 2006
• Last Updated: July 2, 2017

Record last verified: 2006-11-30

Locations

US (1)