NCT00663546

Malaria Studies in Cambodia

Completed Last updated 20 August 2018

What this trial tests

trial in Malaria in 1,978 participants. Completed in 5 December 2013.

Timeline

24 March 2008

5 December 2013

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,978
Start date	24 March 2008
Estimated completion	5 December 2013
Sites	3 locations across Cambodia

Conditions studied

• Malaria — all drugs for Malaria →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Under 100, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

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

1. Independent Origin and Global Distribution of Distinct Plasmodium vivax Duffy Binding Protein Gene Duplications.
   Hostetler JB, Lo E, Kanjee U, Amaratunga C, et al · · 2016 · cited 59× · PMID 27798646 · DOI 10.1371/journal.pntd.0005091
2. Structural basis for neutralization of Plasmodium vivax by naturally acquired human antibodies that target DBP.
   Urusova D, Carias L, Huang Y, Nicolete VC, et al · · 2019 · cited 51× · PMID 31133752 · DOI 10.1038/s41564-019-0461-2
3. Higher microsatellite diversity in Plasmodium vivax than in sympatric Plasmodium falciparum populations in Pursat, Western Cambodia.
   Orjuela-Sánchez P, Sá JM, Brandi MC, Rodrigues PT, et al · · 2013 · cited 50× · PMID 23562882 · DOI 10.1016/j.exppara.2013.03.029
4. A Library of Plasmodium vivax Recombinant Merozoite Proteins Reveals New Vaccine Candidates and Protein-Protein Interactions.
   Hostetler JB, Sharma S, Bartholdson SJ, Wright GJ, et al · · 2015 · cited 48× · PMID 26701602 · DOI 10.1371/journal.pntd.0004264
5. Single-nucleotide polymorphism, linkage disequilibrium and geographic structure in the malaria parasite Plasmodium vivax: prospects for genome-wide association studies.
   Orjuela-Sánchez P, Karunaweera ND, da Silva-Nunes M, da Silva NS, et al · · 2010 · cited 45× · PMID 20626846 · DOI 10.1186/1471-2156-11-65
6. Identification and Characterization of Functional Human Monoclonal Antibodies to <i>Plasmodium vivax</i> Duffy-Binding Protein.
   Carias LL, Dechavanne S, Nicolete VC, Sreng S, et al · · 2019 · cited 29× · PMID 30944159 · DOI 10.4049/jimmunol.1801631
7. SARS-CoV-2 Cross-Reactivity in Prepandemic Serum from Rural Malaria-Infected Persons, Cambodia.
   Manning J, Zaidi I, Lon C, Rosas LA, et al · · 2022 · cited 20× · PMID 35076009 · DOI 10.3201/eid2802.211725
8. Plasmodium knowlesi as a model system for characterising Plasmodium vivax drug resistance candidate genes.
   Verzier LH, Coyle R, Singh S, Sanderson T, et al · · 2019 · cited 17× · PMID 31158222 · DOI 10.1371/journal.pntd.0007470