Skip to main content
OpenTrials
Completed

NCT Number: NCT02143934

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

PNG Institute of Medical Research

Maprik, East Sepik Province, Papua New Guinea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 5-10 years (±3 months)
  • permanent residents of the area
  • absence of history of hypersensitivity reactions to the drugs

Exclusion criteria

  • chronic illness
  • severe malnutrition (weight-for-age nutritional Z score [WAZ] <60th percentile)
  • severe anemia (Hb <5 g/dL),
  • G-6-PD deficiency (<60% G-6-PD activity)
  • permanent disability, which prevents or impedes study participation. Any 1 or more of the criteria is sufficient to exclude study participation.

Treatment and study plan

Primaquine

Drug

Placebo

Drug

Sugar pills, appearance identical to Primaquine tablets

Chloroquine

Drug

Artemether Lumefantrine

Drug

Other names: Coartem

Primary outcomes

  1. Time to first or only Plasmodium vivax infection by light microscopy and PCR

    Time frame: 8 months post-baseline

  2. Time to first or only clinical P. vivax episode

    Time frame: 8 months post-baseline

Secondary outcomes

  1. Time to first or only P. falciparum infection by light microscopy and PCR

    Time frame: 8 months post-baseline

  2. Time to first or only P. ovale infection by light microscopy and PCR

    Time frame: 8 months post-baseline

  3. Time to first or only P. malariae infection by light microscopy and PCR

    Time frame: 8 months post-baseline

Sponsors and collaborators

Lead sponsor

Papua New Guinea Institute of Medical Research

Other Gov

Collaborators

  • Barcelona Centre for International Health Research
  • Swiss Tropical & Public Health Institute
  • Walter and Eliza Hall Institute of Medical Research

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2014
First posted
May 21, 2014
Registry last updated
May 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.