Status:
COMPLETED
Innate and Acquired Resistance to Plasmodium Falciparum Malaria in Mali
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Malaria
Eligibility:
All Genders
6-65 years
Brief Summary
This study, sponsored by NIAID and the University of Bamako, Mali, will identify genetic and other factors that may protect against severe malaria in some children. Children between 6 months and 17 y...
Detailed Description
Hemoglobin (Hb) and red blood cell (RBC) polymorphisms that give rise to HbS, HbC, alpha-thalassemia, G6PD-deficiency, and ABO blood groups occur at high frequency in Mali. To determine whether these ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- (Cohort Study)
- Resident of Kenieroba, Fourda, or Bozokin villages, and no plans to relocate away from the study village for the next 5 years.
- Willingness to participate in the study as evidenced by informed consent of parents or guardians of children, and willingness to bring children to study clinic if they develop fever or other symptoms of malaria.
- Age 6 months to 17 years.
- (Blood Collection Study)
- Children enrolled in the cohort study.
- Willingness to participate in the study as evidenced by informed consent of parents or guardians of children.
- Age 2 years to 14 years.
- Hemoglobin level greater than or equal to 8.5g/dL.
- (Parasite Clearance Study)
- Children enrolled in the cohort study.
- Willingness to participate in the study as evidenced by informed consent of parents or guardians of children.
- Age 1 year to 17 years (inclusive).
- P. falciparum density greater than or equal to 10,000/microL.
- Present with their first episode of uncomplicated malaria of the 2010 transmission season or any episode during the 2012 transmission season.
- Resident of Kenieroba
- (Adult blood Collection Study)
- Willingness to participate in the study as evidenced by informed consent.
- Age 18 years to 65 years.
- Hemoglobin level greater than or equal to 8.5 g/dL
- EXCLUSION CRITERIA:
- (Cohort Study)
- Any condition that in the opinion of the investigator would render the subject unable to comply with the protocol (e.g., psychiatric disease).
- Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary exposure risks to study personnel (e.g., individuals who are known to be HIV-infected or to have AIDS) or to the child (e.g., severe malnutrition).
- (Blood Collection Study)
- Any condition that in the opinion of the investigator would render the subject unable to comply with the protocol (e.g., psychiatric disease).
- Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary exposure risks to study personnel (e.g., individuals who are known to be HIV-infected or to have AIDS) or to the child (e.g., severe malnutrition).
- (Parasite Clearance Study)
- Any condition that in the opinion of the investigator would render the subject unable to comply with the protocol (e.g., psychiatric diesase).
- Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary exposure risks to study personnel (e.g., individuals who are known to be HIV-infected or to have AIDS) or to the child (e.g., severe malnutrition).
- Pregnancy at the time of malaria episode.
- (Adult Blood Collection Study)
- Any condition that in the opinion of the investigator would render the subject unable to comply with the protocol (e.g., psychiatric disease)
- Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary exposure risks to study personnel (e.g., individuals who are known to be HIV-infected or to have AIDS.
Exclusion
Key Trial Info
Start Date :
April 21 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 19 2013
Estimated Enrollment :
1718 Patients enrolled
Trial Details
Trial ID
NCT00669084
Start Date
April 21 2008
End Date
November 19 2013
Last Update
December 17 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology
Bamako, Mali