Malaria Prevention Cambodia

Conditions

Malaria

Keywords

Plasmodium falciparum, Plasmodium vivax

Brief summary

Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.

Detailed description

This is a two arm, randomized, double-blind, placebo controlled cohort study to determine the protective efficacy of a monthly 2 day treatment course of Dihydroartemisinin-Piperaquine (DP) in adult volunteers in malaria endemic areas of Cambodia.

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

Randomized, Double-Blind, Placebo-Controlled Clinical Trial of a Two-Day Regimen of Dihydroartemisinin-Piperaquine for Malaria Prevention Halted for Concern over Prolonged Corrected QT Interval

Jessica E. Manning, Pattaraporn Vanachayangkul, Chanthap Lon, Michele Spring, Mary So et al. (27 authors)

Antimicrobial Agents and Chemotherapy2014-08-0549 citations

10.1128/aac.02667-14

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

DRUGDHA-piperaquine

Drug: Dihydroartemisinin piperaquine 40/320 mg tablets, 9 tablets total Arms: 2 day treatment course (4.5 tablets per day)

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. Volunteer 18-65 years of age 2. Able to give informed consent 3. Likely to reside in malaria 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. Agrees not to seek outside medical care for febrile illness, except in emergency situations, unless referred by study team 6. Authorized by local commander to participate in the study if on active duty

Exclusion criteria

1. Known allergy or other contraindication to DHA, piperaquine treatment, and/or primaquine treatment 2. Significant acute comorbidity requiring urgent medical intervention 3. Positive malaria blood smear. 4. Treatment with an antimalarial drug in the past 30 days. 5. 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 6. Significantly abnormal EKG including a QTcF interval greater than 450ms at baseline (or 470ms for females) using Fridericia's correction 7. Regular current use of known QTc prolonging medications 8. History of sudden cardiac death in an immediate family member, or personal history of known symptomatic coronary artery disease or arrhythmias 9. Judged by the investigator to be otherwise unsuitable for study participation or non-compliant with study requirements

Design outcomes

Primary

Measure	Time frame	Description
Protective efficacy	4 months	To quantify protective efficacy for the prevention of malaria infection in a setting of mixed multidrug resistant P. falciparum and P. vivax malaria, particularly in non-immune volunteers, in two treatment groups - monthly DHA-piperaquine vs. placebo. Protective efficacy will be defined by reduction in the incidence of malaria between treatment and placebo groups.

Secondary

Measure	Time frame	Description
Cardiac safety of piperaquine as determined by QT interval prolongation	4-5 months	To document the effect on the electrocardiogram (EKG), particularly the QTc interval, in patients taking repeated monthly treatment courses of DHA-piperaquine.

Countries

Cambodia

Outcome results

None listed