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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02143934
Enrollment
524
Registered
2014-05-21
Start date
2009-08-31
Completion date
2014-05-31
Last updated
2014-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasmodium Falciparum Clinical Episode, Plasmodium Falciparum Infection, Plasmodium Vivax Clinical Episode, Plasmodium Vivax Infection

Keywords

Plasmodium vivax, Hypnozoites, Primaquine, Liver-stage, Blood-stage, Plasmodium falciparum

Brief 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.

Interventions

DRUGPrimaquine
DRUGPlacebo

Sugar pills, appearance identical to Primaquine tablets

DRUGChloroquine
DRUGArtemether Lumefantrine

Sponsors

Walter and Eliza Hall Institute of Medical Research
CollaboratorOTHER
Swiss Tropical & Public Health Institute
CollaboratorOTHER
Barcelona Centre for International Health Research
CollaboratorOTHER
Papua New Guinea Institute of Medical Research
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Time to first or only clinical P. vivax episode8 months post-baseline
Time to first or only Plasmodium vivax infection by light microscopy and PCR8 months post-baseline

Secondary

MeasureTime frame
Time to first or only P. falciparum infection by light microscopy and PCR8 months post-baseline
Time to first or only P. ovale infection by light microscopy and PCR8 months post-baseline
Time to first or only P. malariae infection by light microscopy and PCR8 months post-baseline

Countries

Papua New Guinea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026