About this trial
The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
Eligibility criteria
Qualifiers
Males and females >=2 years of age and under (<) 65 years of age, weighing >10 kg.
The participant has a positive malarial smear for P. vivax with a parasite density of >100/microliter and <100,000/microliter.
The participant has a screening Hb value >8 g/dL.
The participant has an axillary temperature of 37.5°C or history of fever 48 hours before recruitment.
Disqualifiers
The participant has severe P. vivax malaria as defined by WHO criteria [WHO, 2023].
The participant has a mixed malaria infection (identified by a malarial smear).
The participant has a condition that may affect absorption of study medication, such as severe vomiting (no food or inability to take food during the previous 8 hours).
The participant has a history of porphyria, psoriasis, or epilepsy.
Trial design
Treatments tested in this trial
- Tafenoquine
- Primaquine
- Chloroquine