NCT02143934

Effect of Liver and Blood-stage Treatment on Subsequent Plasmodium Reinfection and Morbidity

Host and Parasites Factors Contributing to Risk of Plasmodium Re-infection and Morbidity in Elementary School Children in Maprik, East Sepik Province

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 524 (actual)
• Sponsor: Papua New Guinea Institute of Medical Research · Other Government
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Accepted

Summary

This study specifically seeks to quantify the contribution of relapes to the burden of P. vivax infections and disease by determining on the effect of radical pre-erythrocytic and erythrocytic clearance on subsequent rates of Plasmodium spp. infection and disease in children aged 5-10 years in a treatment to re-infection study design. In order the clear liver-stage/blood-stages G6PD-normal children were randomised to receive Chloroquine (3 days, standard dose) and Coartem (3 days, standard dose) plus either i) primaquine (20 days, 0.5mg/kg) or ii) placebo (20days). These drugs were administered over a period of 4 weeks. In addition to this epidemiological data, the study will assess the natural acquisition of cellular and humoral immune responses to P. falciparum and P. vivax, thus assisting in the determination of correlates of clinical immunity to P. falciparum and P. vivax in PNG children aged 5-10 years. These data will not only be essential for development of future vaccines against P. vivax and P falciparum but provide invaluable insight into the contribution of long-lasting liver-stages to the force of infection with P. vivax that will contribute towards designing more rational approaches to the treatment of P. vivax both in the context of case management and future attempts at elimination.

Conditions

• Plasmodium Vivax Infection
• Plasmodium Vivax Clinical Episode
• Plasmodium Falciparum Infection
• Plasmodium Falciparum Clinical Episode

Interventions

Type	Name	Description
DRUG	Primaquine
DRUG	Placebo	Sugar pills, appearance identical to Primaquine tablets
DRUG	Chloroquine
DRUG	Artemether Lumefantrine

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-05-01
• Completion: 2014-05-01
• First posted: 2014-05-21
• Last updated: 2014-05-21

Locations

1 site across 1 country: Papua New Guinea