Investigation of Short Course, High Dose Primaquine Treatment for Liver Stages of Plasmodium Vivax Infection
Status:
Unknown status
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
This study specifically seeks to provide data on the safety, tolerability and pilot efficacy
of short course, high dose primaquine treatment in Papua New Guinean children aged 5-10
years, in a cross-sectional study design. Community screened asymptomatic cases and/or cases
of clinically diagnosed malaria admitted to the out-patient units of the health center, will
be screened for Glucose-6-phosphate dehydrogenase deficiency (G6PD) and malaria illness by
rapid diagnostic test and P. vivax infection confirmed by light microscopy. Following
treatment with artemether-lumefantrine (Coartem), G6PD normal children will be enrolled into
the study and followed for 2 months. Primaquine treatment will be allocated to study
participants in a step-wise design; firstly receiving the current 14 day treatment regimen of
0.5 mg/kg total dose (n=40); secondly, a 7 day treatment regimen receiving a total dose of
1.0 mg/kg/day; then thirdly, receive 1.0 mg/kg twice daily dose (bd) for a total of 3.5 days,
should the 7 day treatment prove to be safe and well tolerated. In addition to this
dose-escalation study, the pharmacokinetic profiles of single doses of 0.5 mg/kg and 1.0
mg/kg will be determined using an intensive sampling protocol, in children aged 5-10 years.
The pharmacokinetic profiles obtained by this sub-study will be essential for modeling the
population pharmacokinetic data obtained from the dose-escalation study. As there is
currently no data on the safety, tolerability and efficacy of primaquine in children, the
present study will validate previous observation and contribute to the knowledge of
primaquine as a treatment for liver stages of Plasmodium vivax infection.
Phase:
Phase 4
Details
Lead Sponsor:
Papua New Guinea Institute of Medical Research
Collaborators:
Curtin University Curtin University of Technology The University of Western Australia University of Oxford Walter and Eliza Hall Institute of Medical Research