Vivax Malaria
Conditions
Brief summary
A trial designed to determine whether there is a clinically significant drug-drug interaction of tafenoquine with DHA-piperaquine or artesunate-pyronaridine using a control arm with radical cure given at the end of follow up (delayed radical cure).
Interventions
DRUGTafenoquine plus DHA-Piperaquine
Tafenoquine plus DHA-piperaquine
DRUGTafenoquine plus Artesunate-pyronaridine
Tafenoquine plus Artesunate-pyronaridine
Sponsors
Menzies School of Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* P. vivax peripheral parasitaemia (mono-infection) * G6PD normal status (G6PD activity ≥70% of the adjusted male median * as determined by the Standard G6PD (SD Biosensor, ROK)) * Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours * Age ≥18 years * Haemoglobin at presentation ≥8g/dl * Written informed consent. * Living in the study area and willing to be followed for six months
Exclusion criteria
* Danger signs or symptoms of severe malaria * Pregnant or lactating females * Regular use of drugs with haemolytic potential * Known hypersensitivity to any of the study drugs * History of any psychiatric disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence risk (time to first event) of any P. vivax parasitaemia | 4 months |
Contacts
CONTACTHellen Mnjala
Outcome results
None listed