Malaria Transmission Studies in Mali

NCT01829737 | Completed

• 2 other identifiers: 99991310713-I-N107
• Study Type: observational
• Target: 534
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Malaria is an illness caused by a parasite spread by mosquitoes. When a mosquito bites a person who is infected with a kind of parasite called a gametocyte, it is able to spread the infection to another person. Not everyone infected with parasites have gametocytes in their blood. As a result, not everyone can spread malaria to others. Researchers are interested in learning more about why some healthy people have gametocytes in their blood and others do not. Identifying the people who have gametocytes in their blood can help target treatment and reduce the spread of malaria. This study will focus on the people of the village of Kenieroba in Mali, where malaria is common. Objectives: \- To study the relationship between gametocytes and malaria transmission in Mali. Eligibility: \- Individuals between 6 months and 65 years of age who live in Kenieroba, Mali, and will stay in the area for 1 year. Design:

• For 1 year, participants will have study visits once every 2 weeks (twice a month, for a total of 24 visits). The visits will last 30 minutes each.
• At each visit, participants will provide a small blood sample. They will report any symptoms of malaria such as fever, headache, and body aches. Participants will be encouraged to seek medical treatment if they experience malaria symptoms between visits.
• Participants who have malaria symptoms will have a blood test for malaria parasites. Those who have parasites in the blood will receive antimalarial treatment.
• Three times over 1 year, a larger blood sample will be collected. These blood samples will be taken once in the dry season, once in the wet season, and once in the next dry season.
• Women between 14 and 45 years of age will also provide urine samples to test for pregnancy. Pregnant women will not be asked to give blood samples.

Conditions

Malaria, Falciparum

Keywords

Asymptomatic Parasitemia; RBC Polymorphism; Acquired Immunity

Outcome Measures

Primary Outcomes (1)

• Determine gametocytemia prevalence at each time point relative to age group, asexual parasitemia prevalence, season, and red blood cell polymorphisms, for all cohort enrollees residing in Kenieroba and not treated for malaria during the previous...

  1 year

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:

• Age 6 months to 65 years, inclusive
• Resident of Kenieroba with no plans to relocate away from Kenieroba for 1 year
• Willingness to participate in the study as evidenced by informed consent (if \<18 years, the informed consent of parent or guardian of the child, and assent from children 14 to 17 years old)

You may not qualify if:

• Any condition that in the opinion of the investigator would render the participant 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 the participant (e.g., severe malnutrition)
• Pregnancy for venous blood collections (March 2013, October 2013, March 2014)
• Age 18 to 65 years, inclusive
• Hb level greater than or equal to 8.5 g/dL
• Willingness to participate in the study as evidenced by informed consent
• Pregnancy
• Any condition that in the opinion of the investigator would render the participant 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 the participant (e.g., severe malnutrition)
• Age 2 to 17 years, inclusive
• Hb level greater than or equal to 8.5 g/dL
• Previous enrollment in cohort study on protocol #08-I-N120
• Uncomplicated malaria\*
• P. falciparum density greater than or equal to 10,000/microliters
• Known hemoglobin type HbAA or HbAS

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Faculty of Science and Technology - FST: collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Baker DA. Malaria gametocytogenesis. Mol Biochem Parasitol. 2010 Aug;172(2):57-65. doi: 10.1016/j.molbiopara.2010.03.019. Epub 2010 Apr 8.

  PMID: 20381542 BACKGROUND

• Sachs J, Malaney P. The economic and social burden of malaria. Nature. 2002 Feb 7;415(6872):680-5. doi: 10.1038/415680a.

  PMID: 11832956 BACKGROUND

• Marsh K. Research priorities for malaria elimination. Lancet. 2010 Nov 13;376(9753):1626-7. doi: 10.1016/S0140-6736(10)61499-7. Epub 2010 Oct 28. No abstract available.

  PMID: 21035843 BACKGROUND

• Willcox AC, Huber AS, Diouf A, Barrett JR, Silk SE, Pulido D, King LDW, Alanine DGW, Minassian AM, Diakite M, Draper SJ, Long CA, Miura K. Antibodies from malaria-exposed Malians generally interact additively or synergistically with human vaccine-induced RH5 antibodies. Cell Rep Med. 2021 Jun 21;2(7):100326. doi: 10.1016/j.xcrm.2021.100326. eCollection 2021 Jul 20.

  PMID: 34337556 DERIVED

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne 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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 11, 2013
• Study Start: March 20, 2013
• Primary Completion: January 20, 2015
• Study Completion: January 20, 2015
• Last Updated: August 2, 2018

Record last verified: 2015-01-20

Locations

US (1)