Malaria Active Epidemiology and Treatment Study

NCT01280162 | Completed

• 2 other identifiers: WRAIR # 1737HRPO Log Number A-16251
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

An observational cohort and malaria treatment study in Cambodia.

Conditions

Malaria

Keywords

Plasmodium falciparum, Plasmodium vivax

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

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

  1 year

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

  1 year

Study Arms (2)

3 day therapy

EXPERIMENTAL

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

Drug: Dihydroartemisinin piperaquine

2 day therapy

EXPERIMENTAL

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

Drug: Dihydroartemisinin piperaquine

Interventions

Dihydroartemisinin piperaquine DRUG

40/320 mg tablets, 9 tablets total

Also known as: Artekin, Duo-cotexcin

2 day therapy; 3 day therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Armed Forces Research Institute of Medical Sciences, Thailand: lead
• United States Army Medical Materiel Development Activity: collaborator

Study Sites (1)

Oddar Meancheay

Anlong Veaeng, Cambodia

Location

Related Publications (4)

• 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.

  PMID: 24667662 BACKGROUND

• 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.

  PMID: 28193647 DERIVED

• 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.

  PMID: 26747132 DERIVED

• 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.

  PMID: 25877962 DERIVED

Related Links

• Publication describing results of clinical trial
• Publication describing CYP2D6 alleles in this Cambodian study population

MeSH Terms

Conditions

Malaria; Malaria, Falciparum; Malaria, Vivax

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Michele D. Spring, MD, MSPH

  USAMC-AFRIMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 20, 2011
• Study Start: September 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: December 1, 2012
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

CA (1)