Southeast Asia Dose Optimization of Tafenoquine

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2+
SponsorUniversity of Oxford

About this trial

Tafenoquine was recently approved by regulatory authorities in the USA and Australia. Tafenoquine is an alternative radical curative treatment to primaquine acting against the dormant liver stage of Plasmodium vivax (the hypnozoite). Tafenoquine (an 8-aminoquinoline) has the substantial advantage of single dosing as compared to a 14-day course of primaquine to achieve radical cure. The recommended tafenoquine dose is 300 mg, which was shown to be significantly worse in radical curative efficacy to a total primaquine dose of 3.5 mg/kg in Southeast Asia. The cure rate of tafenoquine 300 mg in Southeast Asian study sites was only 74%. The comparator 3.5 mg/kg total primaquine dose is the standard and most commonly used dose globally, but in Southeast Asia and the Western Pacific, higher doses of primaquine are needed for radical cure. This study aims to determine the optimal dose of tafenoquine in Southeast Asia.

Eligibility criteria

Qualifiers

Patients with symptomatic P. vivax mono-infection as diagnosed by microscopy

Fever or history of fever in the previous 7 days

Quantitative G6PD activity ≥70% of the population median

Weight >10 kg and ≥2 years old

Disqualifiers

Pregnancy

Lactation

Hb < 8 g/dL

Severe malaria

Trial design

Treatments tested in this trial

  • Tafenoquine
  • Chloroquine
  • Artemether 20 mg-Lumefantrine 120 mg

Treatment groups

700 Participants
are divided into 2 treatment groups

Sponsors and collaborators