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Malaria Active Epidemiology and Treatment Study

Primary Purpose

Malaria

Status

Completed

Phase

Not Applicable

Locations

Cambodia

Study Type

Interventional

Intervention

Dihydroartemisinin piperaquine

About this trial

This is an interventional treatment trial for Malaria focused on measuring Plasmodium falciparum, Plasmodium vivax

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

History of allergic reaction or contraindication to DHA or piperaquine
Significant acute comorbidity requiring urgent medical intervention
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
Clinically significant abnormal EKG, including a QTc interval > 500 ms.
Judged by the investigator to be otherwise unsuitable for study participation

Sites / Locations

Oddar Meancheay

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

3 day therapy

2 day therapy

Arm Description

Total dose split over 3 days (3 tablets per day)

Total dose split over 2 days (4.5 tablets per day)

Outcomes

Primary Outcome Measures

Adequate clinical and parasitological response to a treatment regimen of DHA-PIP for Plasmodium falciparum

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 Outcome Measures

Number of Cambodian study subjects with reduced or null activity hepatic cytochrome P450 2D6 alleles

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

For each CYP2D6 genotype determined, use the AS-A system to assign predicted metabolism phenotype

Full Information

NCT ID

NCT01280162

First Posted

January 19, 2011

Last Updated

March 1, 2021

Sponsor

Armed Forces Research Institute of Medical Sciences, Thailand

Collaborators

United States Army Medical Materiel Development Activity

1. Study Identification

Unique Protocol Identification Number

NCT01280162

Brief Title

Malaria Active Epidemiology and Treatment Study

Official Title

An Active Malaria Epidemiology Cohort Study With Evaluation of a 2 Day Versus 3 Day Treatment Regimen of Dihydroartemisinin (DHA)-Piperaquine for Patients With Uncomplicated Malaria

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Armed Forces Research Institute of Medical Sciences, Thailand

Collaborators

United States Army Medical Materiel Development Activity

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

Plasmodium falciparum, Plasmodium vivax

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

222 (Actual)

8. Arms, Groups, and Interventions

Arm Title

3 day therapy

Arm Type

Experimental

Arm Description

Total dose split over 3 days (3 tablets per day)

Arm Title

2 day therapy

Arm Type

Experimental

Arm Description

Total dose split over 2 days (4.5 tablets per day)

Intervention Type

Drug

Intervention Name(s)

Dihydroartemisinin piperaquine

Other Intervention Name(s)

Artekin, Duo-cotexcin

Intervention Description

40/320 mg tablets, 9 tablets total

Primary Outcome Measure Information:

Title

Adequate clinical and parasitological response to a treatment regimen of DHA-PIP for Plasmodium falciparum

Description

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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Number of Cambodian study subjects with reduced or null activity hepatic cytochrome P450 2D6 alleles

Description

Using Polymerase Chain Reaction-based bead array assays, genotype the human hepatic CYP2D6 allele in study participants giving informed consent for genetic testing

Time Frame

1 year

Title

Number of subjects with reduced or null hepatic CYP2D6 enzyme phenotype using activity-score A system

Description

For each CYP2D6 genotype determined, use the AS-A system to assign predicted metabolism phenotype

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Otherwise healthy volunteer, 18-65 years of age, eligible for care at an RCAF facility, and at risk for contracting malaria Able to provide informed consent Likely to reside in endemic area for the duration of the study Available for follow-up for anticipated study duration, and agrees to participate for the duration of the study Authorized by local commander to participate in the study if on active duty Exclusion Criteria: History of allergic reaction or contraindication to DHA or piperaquine Significant acute comorbidity requiring urgent medical intervention 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 Clinically significant abnormal EKG, including a QTc interval > 500 ms. Judged by the investigator to be otherwise unsuitable for study participation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michele D. Spring, MD, MSPH

Organizational Affiliation

USAMC-AFRIMS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oddar Meancheay

City

Anlong Veng

Country

Cambodia

12. IPD Sharing Statement

Citations:

PubMed Identifier

24667662

Citation

Lon C, Manning JE, Vanachayangkul P, So M, Sea D, Se Y, Gosi P, Lanteri C, Chaorattanakawee S, Sriwichai S, Chann S, Kuntawunginn W, Buathong N, Nou S, Walsh DS, Tyner SD, Juliano JJ, Lin J, Spring M, Bethell D, Kaewkungwal J, Tang D, Chuor CM, Satharath P, Saunders D. Efficacy of two versus three-day regimens of dihydroartemisinin-piperaquine for uncomplicated malaria in military personnel in northern Cambodia: an open-label randomized trial. PLoS One. 2014 Mar 25;9(3):e93138. doi: 10.1371/journal.pone.0093138. eCollection 2014.

Results Reference

background

PubMed Identifier

28193647

Citation

Vanachayangkul P, Lon C, Spring M, Sok S, Ta-Aksorn W, Kodchakorn C, Pann ST, Chann S, Ittiverakul M, Sriwichai S, Buathong N, Kuntawunginn W, So M, Youdaline T, Milner E, Wojnarski M, Lanteri C, Manning J, Prom S, Haigney M, Cantilena L, Saunders D. Piperaquine Population Pharmacokinetics and Cardiac Safety in Cambodia. Antimicrob Agents Chemother. 2017 Apr 24;61(5):e02000-16. doi: 10.1128/AAC.02000-16. Print 2017 May.

Results Reference

derived

PubMed Identifier

26747132

Citation

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. Antibody profiles to plasmodium merozoite surface protein-1 in Cambodian adults during an active surveillance cohort with nested treatment study. Malar J. 2016 Jan 8;15:17. doi: 10.1186/s12936-015-1058-8.

Results Reference

derived

PubMed Identifier

25877962

Citation

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. Dihydroartemisinin-piperaquine failure associated with a triple mutant including kelch13 C580Y in Cambodia: an observational cohort study. Lancet Infect Dis. 2015 Jun;15(6):683-91. doi: 10.1016/S1473-3099(15)70049-6. Epub 2015 Apr 12.

Results Reference

derived

Links:

URL

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0093138

Description

Publication describing results of clinical trial

URL

https://www.ajtmh.org/content/journals/10.4269/ajtmh.20-0061

Description

Publication describing CYP2D6 alleles in this Cambodian study population

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Malaria Active Epidemiology and Treatment Study

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