Malaria Active Epidemiology and Treatment Study

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280162
• Other study ID #: WRAIR # 1737
• Secondary ID: HRPO Log Number
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2021
• Source: Armed Forces Research Institute of Medical Sciences, Thailand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An observational cohort and malaria treatment study in Cambodia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: December 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Dihydroartemisinin piperaquine
40/320 mg tablets, 9 tablets total

Locations

Country	Name	City	State
Cambodia	Oddar Meancheay	Anlong Veng

Sponsors (2)

Lead Sponsor	Collaborator
Armed Forces Research Institute of Medical Sciences, Thailand	United States Army Medical Materiel Development Activity

Country where clinical trial is conducted

Cambodia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	1 year
Secondary	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	1 year

External Links

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