Evaluation of Safety and Efficacy of Two Primaquine Dosing Regimens for the Radical Treatment of Plasmodium Vivax Malaria in Vanuatu and Solomon Islands

Study start date: May 1, 2013

Inclusion Criteria: Age 12 months to 60 years Melanesian background and living in local area Microscopically (based on field microscopy) or RDT confirmed P.vivax regardless of parasite density. Mixed infections (P.falciparum-P.vivax and P.malariae-P.vivax) can be included. Exclusion Criteria: Any signs of severe malaria (see WHO definitions) including: impaired consciousness, respiratory distress, severe anaemia (Hb<5), multiple seizures, frequent vomiting/ inability to swallow tablets, prostration, jaundice, hypotension, abnormal bleeding or hypoglycaemia. Clinical evidence of non-malarial illness (such as pneumonia or otitis media) Severe malnutrition (weight-for-age nutritional Z score [WAZ] <60th percentile) Permanent disability, which prevents or impedes study participation. Treatment with primaquine in the previous 14 days Residence or planned travel outside the study area during the follow-up period (precluding supervised treatment and follow-up procedures) Known or suspected pregnancy Currently breastfeeding A positive rapid test for G6PD deficiency (Binax or Carestart RDT) Following later PCR-based confirmation of malaria speciation, there may be some post-hoc exclusion of subjects in whom it is thought the initial field-based microscopic diagnosis may have been incorrect.