Short course radical cure of P. vivax in Nepal – a randomized controlled trial – pilot study (SIRIN)

The current regimen for P. vivax radical cure requires a 14-day course of primaquine, but the long course of treatment means that many patients don’t complete their medication and thus fail treatment.

In Nepal recent evidence suggests that a low dose regimen of 3.5mg/kg total dose is effective in preventing recurrent episodes of vivax malaria. Shortening this course is likely to increase adherence and therefore effectiveness.

In addition, in co-endemic areas, up to half of patients treated for P. falciparum malaria representing with P. vivax malaria. We hypothesize that this is due to the P. falciparum parasite triggering a P. vivax relapse. Hence, in some co-endemic regions there is a good rationale for eradicating P. vivax hypnozoites from the liver in patients presenting with uncomplicated P. falciparum infections. In close collaboration with the Nepal National Malaria Program we are conducting a randomized, open label pilot study to assess the safety and efficacy of a shortened PQ treatment (3.5mg/kg total dose given over 7 days) in G6PD normal patients with P. vivax and P. falciparum to reduce the risk of subsequent P. vivax episodes.

• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment

ClinicalTrials.gov Identifier: NCT04079621

Clinical trial registrationMenzies project details

Drug-based Strategies
P. vivax

Oct 2021 — Jun 2023

Nepal