Malaria Active Epidemiology and Treatment Study

Conditions

Malaria

Keywords

Plasmodium falciparum, Plasmodium vivax

Brief summary

An observational cohort and malaria treatment study in Cambodia.

Detailed description

This is an active observational Cohort Study of malaria epidemiology with a nested two arm, randomized, open label Treatment Study comparing the efficacy, safety, tolerability and pharmacokinetics of a two versus three day course of Dihydroartemisinin-Piperaquine (DP) for those developing uncomplicated malaria. At the conclusion of the Cohort Study, a subset of volunteers with documented exposure to Plasmodium vivax during the study will be treated with primaquine as presumptive anti-relapse therapy directed against the exoerythrocytic malaria stages of P. vivax, and followed passively for an additional 6 months.

Pattaraporn Vanachayangkul, Chanthap Lon, Michele Spring, Sommethy Sok, Winita Ta-aksorn et al. (22 authors)

Antimicrobial Agents and Chemotherapy2017-02-1420 citations

10.1128/aac.02000-16

Antibody profiles to plasmodium merozoite surface protein-1 in Cambodian adults during an active surveillance cohort with nested treatment study.

Spring MD, Pichyangkul S, Lon C, Gosi P, Yongvanichit K, Srichairatanakul U, Limsalakpeth A, Chaisatit C, Chann S, Sriwichai S, Auayapon M, Chaorattanakawee S, Dutta S, Prom S, Meng Chour C, Walsh DS, Angov E, Saunders DL.

2016-01-086 citations

10.1186/s12936-015-1058-8

Dihydroartemisinin-piperaquine failure associated with a triple mutant including kelch13 C580Y in Cambodia: an observational cohort study.

Spring MD, Lin JT, Manning JE, Vanachayangkul P, Somethy S, Bun R, Se Y, Chann S, Ittiverakul M, Sia-ngam P, Kuntawunginn W, Arsanok M, Buathong N, Chaorattanakawee S, Gosi P, Ta-aksorn W, Chanarat N, Sundrakes S, Kong N, Heng TK, Nou S, Teja-isavadharm P, Pichyangkul S, Phann ST, Balasubramanian S, Juliano JJ, Meshnick SR, Chour CM, Prom S, Lanteri CA, Lon C, Saunders DL.

2015-04-12207 citations

10.1016/s1473-3099(15)70049-6

Efficacy of Two versus Three-Day Regimens of Dihydroartemisinin-Piperaquine for Uncomplicated Malaria in Military Personnel in Northern Cambodia: An Open-Label Randomized Trial

Chanthap Lon, Jessica E. Manning, Pattaraporn Vanachayangkul, Mary So, Darapiseth Sea et al. (25 authors)

PLoS ONE2014-03-2559 citations

10.1371/journal.pone.0093138

Interventions

DRUGDihydroartemisinin piperaquine

40/320 mg tablets, 9 tablets total

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. Otherwise healthy volunteer, 18-65 years of age, eligible for care at an RCAF facility, and at risk for contracting malaria 2. Able to provide informed consent 3. Likely to reside in endemic area for the duration of the study 4. Available for follow-up for anticipated study duration, and agrees to participate for the duration of the study 5. Authorized by local commander to participate in the study if on active duty

Exclusion criteria

1. History of allergic reaction or contraindication to DHA or piperaquine 2. Significant acute comorbidity requiring urgent medical intervention 3. Pregnant or lactating female, or a female of childbearing age who does not agree to use a highly effective method of birth control during the study 4. Clinically significant abnormal EKG, including a QTc interval \> 500 ms. 5. Judged by the investigator to be otherwise unsuitable for study participation

Design outcomes

Primary

Measure	Time frame	Description
Adequate clinical and parasitological response to a treatment regimen of DHA-PIP for Plasmodium falciparum	6 months	Number of malaria recurrences for 2 and 3 day DHA-PIP drug regimens within 42 days after treatment of malaria infection, diagnosed by positive PCR-corrected malaria microscopy.

Secondary

Measure	Time frame	Description
Number of Cambodian study subjects with reduced or null activity hepatic cytochrome P450 2D6 alleles	1 year	Using Polymerase Chain Reaction-based bead array assays, genotype the human hepatic CYP2D6 allele in study participants giving informed consent for genetic testing
Number of subjects with reduced or null hepatic CYP2D6 enzyme phenotype using activity-score A system	1 year	For each CYP2D6 genotype determined, use the AS-A system to assign predicted metabolism phenotype

Countries

Cambodia

Outcome results

None listed