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

Phase 4

Completed

• Conditions: Plasmodium Vivax Infection; Plasmodium Vivax Clinical Episode; Plasmodium Falciparum Infection; Plasmodium Falciparum Clinical Episode
• Interventions: Drug: Placebo; Drug: Primaquine; Drug: Chloroquine; Drug: Artemether Lumefantrine

• Registration Number: NCT02143934
• Lead Sponsor: Papua New Guinea Institute of Medical Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2010-05
• Status Verified: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-19
• Last Update Submitted: 2014-05-19
• Study First Posted: 2014-05-21
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 524

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primaquine	Artemether Lumefantrine	Primaquine, 0.5mg/kg/day, 20 days directly observed treatment Chloroquine, 25mg/kg total dose, divided over 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD
Placebo	Placebo	Placebo, 20 days directly observed treatment Chloroquine, mg/kg, 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD
Placebo	Chloroquine	Placebo, 20 days directly observed treatment Chloroquine, mg/kg, 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD
Placebo	Artemether Lumefantrine	Placebo, 20 days directly observed treatment Chloroquine, mg/kg, 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD
Primaquine	Primaquine	Primaquine, 0.5mg/kg/day, 20 days directly observed treatment Chloroquine, 25mg/kg total dose, divided over 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD
Primaquine	Chloroquine	Primaquine, 0.5mg/kg/day, 20 days directly observed treatment Chloroquine, 25mg/kg total dose, divided over 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD

Primary Outcome Measures

Name	Time	Method
Time to first or only Plasmodium vivax infection by light microscopy and PCR	8 months post-baseline
Time to first or only clinical P. vivax episode	8 months post-baseline

Secondary Outcome Measures

Name	Time	Method
Time to first or only P. falciparum infection by light microscopy and PCR	8 months post-baseline
Time to first or only P. ovale infection by light microscopy and PCR	8 months post-baseline
Time to first or only P. malariae infection by light microscopy and PCR	8 months post-baseline

Trial Locations

Locations (1)

PNG Institute of Medical Research; 🇵🇬 Maprik, East Sepik Province, Papua New Guinea