Malaria Studies in Cambodia

NCT00663546 | Completed

• 2 other identifiers: 99990809408-I-N094
• Study Type: observational
• Target: 1,978
• Locations: 1 country
• Sites: 3

Brief Summary

This study, conducted by the National Center for Parasitology, Entomology and Malaria Control of Cambodia s Ministry of Health and the National Institute of Allergy and Infectious Diseases, will explore whether the following factors confer protection against malaria and associated anemia: certain blood groups, the hemoglobin E variant, G6PD-deficiency and alpha-thalassemia. Malaria is caused by parasites (P. falciparum and P. vivax) that are transmitted to humans through mosquito bites. This protocol includes two studies, a cohort study and a P. vivax collection study. Individuals are eligible for enrollment in the studies as follows: Cohort study: Residents of all ages of Kandal, Ekapheap and Sangkumthmey villages (Thmar Da commune) who plan to remain in Thmar Da commune for the next 5 years. P. vivax collection study: 2 years of age and older Participating in NIAID protocol 05-I- N210 ( Severe Malaria and Anti-malarial Drug Resistance in Cambodia ) and diagnosed with P. vivax malaria Participants undergo the following procedures: Cohort study: Baseline evaluation, including the following:

• Collection of demographic information
• Malaria history, temperature measurement and review of current symptoms, if any
• Blood draw of 300 microliters
• Additional blood draw of 10 milliliters in selected adults 18 years of age and older Treatment with artesunate-piperaquine at a commune health post for subjects who develop malaria Contact once a year for 5 years to determine continued residency in Thmar Da commune P. vivax collection study:
• Medical history and physical examination
• Hemoglobin level measurement
• Blood draw
• Treatment with chloroquine
• Blood draw 3 to 5 weeks after treatment in some patients 18 years of age or older

Conditions

Malaria

Keywords

Malaria; Plasmodium; Hemoglobin E; Alpha-thalssemia; G6PD Deficiency

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Resident of Kandal, Ekapheap, and Sangkumthmey villages (Thmar Da commune), and no plans to leave the Thmar Da commune for the next 5 years.
• Willingness to participate in the study as evidenced by informed consent of subjects or his/her parent or guardian, and willingness to come to commune health posts if he/she develops fever or other symptoms of malaria.
• Individuals of all ages will be enrolled.

You may not qualify if:

• 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).
• P. vivax malaria (mono-infection).
• Willingness to participate in the study as evidenced by informed consent of subjects or his/her parent or guardian.
• Age greater than or equal to 2.
• Hematocrit greater than or equal to 25%.
• 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).
• Pregnancy.
• Prior use of antimalarials during the past 2 months.
• Healthy male or female adults greater than or equal to 18 years old or healthy pregnant female adults greater than or equal to 18 years old.
• Willingness to participate in the study as evidenced by informed consent.
• 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).
• Healthy male or non- pregnant female adults greater than or equal to 18 years old.

Sponsors & Collaborators

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

Study Sites (3)

National Center for Parasitology, Entomology, and Malaria Controk, Ministry of H

Phnom Penh, Cambodia

Location

Preah Vihear Referral Hospital

Preah Vihear Province, Cambodia

Location

Ratanakiri Referral Hospital

Ratanakiri Province, Cambodia

Location

Related Publications (6)

• Frischer H, Bowman J. Hemoglobin E, an oxidatively unstable mutation. J Lab Clin Med. 1975 Apr;85(4):531-9.

  PMID: 1120926 BACKGROUND

• Lachant NA, Tanaka KR. Impaired antioxidant defense in hemoglobin E-containing erythrocytes: a mechanism protective against malaria? Am J Hematol. 1987 Nov;26(3):211-9. doi: 10.1002/ajh.2830260302.

  PMID: 3674003 BACKGROUND

• Hill AV. Molecular epidemiology of the thalassaemias (including haemoglobin E). Baillieres Clin Haematol. 1992 Jan;5(1):209-38. doi: 10.1016/s0950-3536(11)80042-9.

  PMID: 1596592 BACKGROUND

• Fantin RF, Coelho CH, Berhe AD, Magalhaes LMD, Pereira DB, Salinas ND, Tolia NH, Amaratunga C, Suon S, Sagara I, Narum DL, Fujiwara RT, Abejon C, Campos-Neto A, Duffy PE, Bueno LL. Immunological characterization of a VIR protein family member (VIR-14) in Plasmodium vivax-infected subjects from different epidemiological regions in Africa and South America. PLoS Negl Trop Dis. 2023 Apr 7;17(4):e0011229. doi: 10.1371/journal.pntd.0011229. eCollection 2023 Apr.

  PMID: 37027391 DERIVED

• Hostetler JB, Sharma S, Bartholdson SJ, Wright GJ, Fairhurst RM, Rayner JC. A Library of Plasmodium vivax Recombinant Merozoite Proteins Reveals New Vaccine Candidates and Protein-Protein Interactions. PLoS Negl Trop Dis. 2015 Dec 23;9(12):e0004264. doi: 10.1371/journal.pntd.0004264. eCollection 2015 Dec.

  PMID: 26701602 DERIVED

• Amaratunga C, Sreng S, Mao S, Tullo GS, Anderson JM, Chuor CM, Suon S, Fairhurst RM. Chloroquine remains effective for treating Plasmodium vivax malaria in Pursat province, Western Cambodia. Antimicrob Agents Chemother. 2014 Oct;58(10):6270-2. doi: 10.1128/AAC.03026-14. Epub 2014 Jul 21.

  PMID: 25049249 DERIVED

MeSH Terms

Conditions

Malaria; Glucosephosphate Dehydrogenase Deficiency

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; 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 19, 2008
• First Posted: April 22, 2008
• Study Start: March 24, 2008
• Study Completion: December 5, 2013
• Last Updated: August 20, 2018

Record last verified: 2013-12-05

Locations

CA (3)