The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
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.
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.
Parallel
Tafenoquine
DrugA single dose of TQ will be administered orally on Day 1 or Day 2.
Primaquine
DrugA single dose of PQ will be administered orally, daily, on Day 1 or 2 to Day 14 (or Day 15 if PQ started on Day 2).
Chloroquine
DrugA single dose of CQ will be administered orally, daily, on Days 1 to 3.
Number of participants remaining recurrence-free during the 6 months post-treatment and have a negative blood smear at the Month 6 (end of study [EOS]) visit
Two consecutive negative blood smears between Day 2 and Day 8, no positive blood smear for P. vivax parasites at any point during the 6-month follow-up period, and a negative P. vivax smear at the 6-month assessment.
Number of participants with clinically relevant hemolysis change from baseline
A decrease in hemoglobin of greater than or equal to (\>=) 30% or greater than (\>) 3g/deciliter (dL) from baseline; or an overall drop in hemoglobin below 6.0 g/dL or complications thereof (e.g., required transfusions, acute renal failure) are considered clinically relevant hemolysis changes.
Time to recurrence of P. vivax malaria
Recurrence is defined as a positive blood smear for P. vivax parasites within the 6-month follow-up period, after clearance of blood-stage parasitemia.
Number of participants with treatment emergent adverse events (TEAEs) up to Month 6
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Number of participants with TEAEs meeting >= Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 criteria
Severity was graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening, Grade 5-Death.
Click on the lead sponsor to view all of their trials.
