Collaborators:
  • Tribhuvan University, Kathmandu, Nepal
  • Department of Health Services, Ministry of Health and Population, Nepal
Funders:
  • Australian Academy of Science
  • Bill and Melinda Gates Foundation
Photo credits:
  • Pearl Gan in association with OUCRU, Vietnam and EOCRU, Indonesia.
Short course radical cure of P. vivax in Nepal - a randomized controlled trial – pilot study (SIRIN)
 
Aim:

To simplify malaria treatment in Nepal by reducing the treatment course of primaquine radical cure for P. vivax malaria.

Rationale:

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 malaria1. 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 2,3. 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.

Implications for policy and practice:

Shortening the course and providing unified treatment options for malaria is likely to have programmatic advantages and could reduce the burden of malaria in Nepal, delivering a large public health benefit.

Study title:

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

Aims:

Assess the efficacy of a 7-day low dose course of primaquine (3.5mg/kg total dose) for the radical cure of P. vivax malaria in mixed malaria infections.

Objectives:

Primary:

  • To assess the safety and efficacy of a 7-day course of primaquine in preventing recurrent symptomatic P. vivax in G6PD normal patients following uncomplicated P. vivax and P. falciparum malaria.

Secondary:

  • To assess the efficacy of a 7-day course of primaquine in preventing recurrent symptomatic and asymptomatic P. vivax parasitaemia
  • To assess the safety of a 7-day course of primaquine treatment

For more information visit the clinical trials website. 

Project dates:

The trial has commenced. 

Project team:

Chief investigator:

Project manager:

  • Contact Hellen Mnjala for further information about the study.

Investigators:

  • Dr Prakash Ghimire, Tribhuvan University, Nepal
  • Dr Bibek Lal, National Malaria Control Program, Department of Health Services, Ministry of Health and Population, Nepal
  • Dr Benedikt Ley, Menzies School of Health Research
  • Professor Ric Price, Menzies School of Health Research