NCT00669084

Innate and Acquired Resistance to Plasmodium Falciparum Malaria in Mali

Completed Last updated 17 December 2019

What this trial tests

trial in Malaria in 1,718 participants. Completed in 19 November 2013.

Timeline

21 April 2008

19 November 2013

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,718
Start date	21 April 2008
Estimated completion	19 November 2013
Sites	1 location across Mali

Conditions studied

• Malaria — all drugs for Malaria →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 6 Months to 65, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

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Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Functional comparison of Plasmodium falciparum transmission-blocking vaccine candidates by the standard membrane-feeding assay.
   Miura K, Takashima E, Deng B, Tullo G, et al · · 2013 · cited 105× · PMID 24042109 · DOI 10.1128/iai.01056-13
2. Plasmodium falciparum clearance rates in response to artesunate in Malian children with malaria: effect of acquired immunity.
   Lopera-Mesa TM, Doumbia S, Chiang S, Zeituni AE, et al · · 2013 · cited 58× · PMID 23448727 · DOI 10.1093/infdis/jit082
3. Effect of red blood cell variants on childhood malaria in Mali: a prospective cohort study.
   Lopera-Mesa TM, Doumbia S, Konaté D, Anderson JM, et al · · 2015 · cited 51× · PMID 26687956 · DOI 10.1016/s2352-3026(15)00043-5
4. Plasmodium falciparum clearance is rapid and pitting independent in immune Malian children treated with artesunate for malaria.
   Ndour PA, Lopera-Mesa TM, Diakité SA, Chiang S, et al · · 2015 · cited 45× · PMID 25183768 · DOI 10.1093/infdis/jiu427
5. Plasma uric acid levels correlate with inflammation and disease severity in Malian children with Plasmodium falciparum malaria.
   Lopera-Mesa TM, Mita-Mendoza NK, van de Hoef DL, Doumbia S, et al · · 2012 · cited 42× · PMID 23071567 · DOI 10.1371/journal.pone.0046424
6. Immunoscreening of Plasmodium falciparum proteins expressed in a wheat germ cell-free system reveals a novel malaria vaccine candidate.
   Morita M, Takashima E, Ito D, Miura K, et al · · 2017 · cited 38× · PMID 28378857 · DOI 10.1038/srep46086
7. Standardization of the antibody-dependent respiratory burst assay with human neutrophils and Plasmodium falciparum malaria.
   Llewellyn D, Miura K, Fay MP, Williams AR, et al · · 2015 · cited 21× · PMID 26373337 · DOI 10.1038/srep14081
8. A potential role for plasma uric acid in the endothelial pathology of Plasmodium falciparum malaria.
   Mita-Mendoza NK, van de Hoef DL, Lopera-Mesa TM, Doumbia S, et al · · 2013 · cited 16× · PMID 23349902 · DOI 10.1371/journal.pone.0054481