Actively Recruiting
Investigating the Pharmacokinetics of Tafenoquine in Healthy Papua New Guinean Children
Led by Curtin University · Updated on 2026-03-18
30
Participants Needed
1
Research Sites
18 weeks
Total Duration
On this page
Sponsors
C
Curtin University
Lead Sponsor
P
Papua New Guinea Institute of Medical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Plasmodium vivax is the most geographically widespread malaria species and the second largest contributor to symptomatic malaria worldwide. It accounts for half of all malaria cases outside Africa, with an estimated 14.3 million clinical vivax malaria cases reported annually, contributing to an annual cost of US$359 million. Children are most vulnerable to infection, with P. vivax prevalence peaking between 2 to 6 years of age. In Papua New Guinea (PNG), there are \>1.5 million suspected P. vivax cases annually, and while P. falciparum infections are the most prevalent, P. vivax transmission is the most intense in the world. P. vivax in PNG provides a unique epidemiological setting in which to assess innovative treatments in children. The complex biology of P. vivax represents a challenge for malaria control and chemotherapy, especially dormant liver-stage parasites (hypnozoites) which can reactivate (relapse) and cause disease at a time remote from the primary infection. Hypnozoite relapse is the primary cause of vivax malaria in endemic regions and is resistant to most antimalarial drugs. Identifying effective treatments for radical cure, the complete elimination of parasites (both blood- and liver-stage), is therefore a priority. The World Health Organization (WHO) recommends a 14-day radical cure regimen for uncomplicated vivax malaria; comprised of blood stage treatment (chloroquine or artemisinin combination therapy (ACT)) and 14 days of the 8-aminoquinoline drug primaquine (PQ; 0.25-0.5 mg/kg/day) for liver-stage cure. More recently, the 8-aminoquinoline tafenoquine has garnered interest as an alternative radical cure agent to primaquine. However, there is limited data on the pharmacokinetics, tolerability and radical cure efficacy of tafenoquine in children. The overall aim of the study is to characterise the pharmacokinetic profile of tafenoquine (and primary metabolite) in Papua New Guinean children.
CONDITIONS
Official Title
Investigating the Pharmacokinetics of Tafenoquine in Healthy Papua New Guinean Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have normal glucose-6-phosphate-dehydrogenase (G6PD) activity above 70% enzyme activity confirmed by quantitative test
- Test negative for malaria by rapid diagnostic test
- Have not received antimalarial treatment in the past 4 weeks
- Have no signs or symptoms of significant illness
- Have no history of hypersensitivity to primaquine
- Are able to attend all scheduled follow-up visits
You will not qualify if you...
- Have G6PD activity below 70%
- Test positive for malaria by rapid diagnostic test
- Have received antimalarial treatment in the past 4 weeks
- Have signs or symptoms of significant illness
- Have a history of hypersensitivity to primaquine
- Are unable or unwilling to attend all scheduled follow-up visits
AI-Screening
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Trial Site Locations
Total: 1 location
1
Alexishafen Health Centre
Madang, Madang Province, Papua New Guinea, MP511
Actively Recruiting
Research Team
B
Brioni R Moore, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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