Innate and Acquired Resistance to Plasmodium Falciparum Malaria in Mali

NCT00669084 | Completed

• 2 other identifiers: 99990812008-I-N120
• Study Type: observational
• Target: 1,718
• Locations: 1 country
• Sites: 1

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 years of age who live in Kenieroba, Fourda or Bozokin villages in Mali may enroll in the study. Participants have a blood sample collected by finger prick with a small needle. The blood is examined for gene variants that influence the severity of disease in children exposed to the malaria parasite. Children who develop a fever or other symptoms of malaria are evaluated and treated in Kenieroba s health center for up to 5 years from entering the study, or until they reach 18 years of age. The children are treated with artesunate and amodiaquine. Children with severe disease are treated with quinine. One tablespoon of blood is drawn from the children for study. At the end of the dry season and the wet season, a subset of 200 healthy children are asked to provide 1 or 2 tablespoons of blood, drawn through a needle placed in a vein in the arm. Additional research blood samples may be requested from children between 2 and 17 years old. Blood will not be taken from any child more than twice a year. ...

Conditions

Malaria

Keywords

Innate Immunity; Malaria; Plasmodium; Hemoglobinopathy; G6PD Deficiency

Eligibility Criteria

• Age: 6 Months - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

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

Study Sites (1)

University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology

Bamako, Mali

Location

Related Publications (8)

• Fairhurst RM, Baruch DI, Brittain NJ, Ostera GR, Wallach JS, Hoang HL, Hayton K, Guindo A, Makobongo MO, Schwartz OM, Tounkara A, Doumbo OK, Diallo DA, Fujioka H, Ho M, Wellems TE. Abnormal display of PfEMP-1 on erythrocytes carrying haemoglobin C may protect against malaria. Nature. 2005 Jun 23;435(7045):1117-21. doi: 10.1038/nature03631.

  PMID: 15973412 BACKGROUND

• Guindo A, Fairhurst RM, Doumbo OK, Wellems TE, Diallo DA. X-linked G6PD deficiency protects hemizygous males but not heterozygous females against severe malaria. PLoS Med. 2007 Mar;4(3):e66. doi: 10.1371/journal.pmed.0040066.

  PMID: 17355169 BACKGROUND

• Luzzatto L, Usanga FA, Reddy S. Glucose-6-phosphate dehydrogenase deficient red cells: resistance to infection by malarial parasites. Science. 1969 May 16;164(3881):839-42. doi: 10.1126/science.164.3881.839.

  PMID: 4889647 BACKGROUND

• Suresh RV, Deng B, Gebremicale Y, Roche K, Miura K, Long C. Mesenchymal stem cells of the bone marrow raise infectivity of Plasmodium falciparum gametocytes. mBio. 2023 Dec 19;14(6):e0223223. doi: 10.1128/mbio.02232-23. Epub 2023 Nov 1.

  PMID: 37909740 DERIVED

• Lopera-Mesa TM, Doumbia S, Konate D, Anderson JM, Doumbouya M, Keita AS, Diakite SA, Traore K, Krause MA, Diouf A, Moretz SE, Tullo GS, Miura K, Gu W, Fay MP, Taylor SM, Long CA, Diakite M, Fairhurst RM. Effect of red blood cell variants on childhood malaria in Mali: a prospective cohort study. Lancet Haematol. 2015 Apr;2(4):e140-9. doi: 10.1016/S2352-3026(15)00043-5. Epub 2015 Mar 24.

  PMID: 26687956 DERIVED

• Lopera-Mesa TM, Doumbia S, Chiang S, Zeituni AE, Konate DS, Doumbouya M, Keita AS, Stepniewska K, Traore K, Diakite SA, Ndiaye D, Sa JM, Anderson JM, Fay MP, Long CA, Diakite M, Fairhurst RM. Plasmodium falciparum clearance rates in response to artesunate in Malian children with malaria: effect of acquired immunity. J Infect Dis. 2013 Jun 1;207(11):1655-63. doi: 10.1093/infdis/jit082. Epub 2013 Feb 28.

  PMID: 23448727 DERIVED

• Mita-Mendoza NK, van de Hoef DL, Lopera-Mesa TM, Doumbia S, Konate D, Doumbouya M, Gu W, Anderson JM, Santos-Argumedo L, Rodriguez A, Fay MP, Diakite M, Long CA, Fairhurst RM. A potential role for plasma uric acid in the endothelial pathology of Plasmodium falciparum malaria. PLoS One. 2013;8(1):e54481. doi: 10.1371/journal.pone.0054481. Epub 2013 Jan 22.

  PMID: 23349902 DERIVED

• Lopera-Mesa TM, Mita-Mendoza NK, van de Hoef DL, Doumbia S, Konate D, Doumbouya M, Gu W, Traore K, Diakite SA, Remaley AT, Anderson JM, Rodriguez A, Fay MP, Long CA, Diakite M, Fairhurst RM. Plasma uric acid levels correlate with inflammation and disease severity in Malian children with Plasmodium falciparum malaria. PLoS One. 2012;7(10):e46424. doi: 10.1371/journal.pone.0046424. Epub 2012 Oct 5.

  PMID: 23071567 DERIVED

MeSH Terms

Conditions

Malaria; Hemoglobinopathies; Glucosephosphate Dehydrogenase Deficiency

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rick M Fairhurst, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 26, 2008
• First Posted: April 29, 2008
• Study Start: April 21, 2008
• Study Completion: November 19, 2013
• Last Updated: December 17, 2019

Record last verified: 2013-11-19

Locations

MA (1)