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

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

DRUG

Primaquine

DRUG

Placebo

Sugar pills, appearance identical to Primaquine tablets

DRUG

Chloroquine

DRUG

Artemether Lumefantrine

Sponsors & Collaborators

• Walter and Eliza Hall Institute of Medical Research

  collaborator OTHER

• Swiss Tropical & Public Health Institute

  collaborator OTHER

• Barcelona Centre for International Health Research

  collaborator OTHER

• Papua New Guinea Institute of Medical Research

  lead OTHER_GOV

Principal Investigators

• Ivo Mueller, PhD · Walter and Eliza Hall Institute of Medical Research; Centre de Recerca en Salut Internacional de Barcelona (CRESIB)

• Inoni Betuela, MD PhD · PNG Institute of Medical Research

• Louis Schofield, PhD · Walter and Eliza Hall Institute of Medical Research

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

10 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-08-31

Primary Completion

2010-05-31

Completion

2014-05-31

Countries

• Papua New Guinea

Study Locations