An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-64
SponsorGlaxoSmithKline

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

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators