Status:
COMPLETED
Study of Factors Involved in Resistance to Severe Malaria
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Malaria
Eligibility:
All Genders
2-10 years
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 malar...
Detailed Description
Malaria remains an important public health threat, responsible for over two million deaths annually, the majority among African children. The mechanisms underlying resistance to the most severe manife...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA -MALARIA PATIENTS:
- 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.
- INCLUSION CRITERIA -HEALTHY VOLUNTEERS:
- 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-MALARIA PATIENTS:
- 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.
- EXCLUSION CRITERIA-HEALTHY VOLUNTEERS:
- 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.
Exclusion
Key Trial Info
Start Date :
February 21 2006
Trial Type :
OBSERVATIONAL
End Date :
November 30 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00368810
Start Date
February 21 2006
End Date
November 30 2006
Last Update
July 2 2017
Active Locations (1)
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1
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States, 20892