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

Plasmodium Falciparum Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143934
• Other study ID #: 07200734
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2014
• Last updated: May 19, 2014
• Start date: August 2009
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Papua New Guinea Institute of Medical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Papua New Guinea: PNGIMR Institutional Review BoardPapua New Guinea: PNG Medical Research Advisory Committee, PNG National Department of HealthAustralia: Walter and Eliza Hall Institute of Medical Research Human Ethics CommitteeSwitzerland: Ethics Committee of Basel
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 524
• Est. completion date: May 2014
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 10 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Malaria
• Plasmodium Falciparum Clinical Episode
• Plasmodium Falciparum Infection
• Plasmodium Vivax Clinical Episode
• Plasmodium Vivax Infection

Intervention

Drug:
• Primaquine

• Placebo
Sugar pills, appearance identical to Primaquine tablets
• Chloroquine

• Artemether Lumefantrine

Locations

Country	Name	City	State
Papua New Guinea	PNG Institute of Medical Research	Maprik	East Sepik Province

Sponsors (4)

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

Country where clinical trial is conducted

Papua New Guinea, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first or only Plasmodium vivax infection by light microscopy and PCR		8 months post-baseline	No
Primary	Time to first or only clinical P. vivax episode		8 months post-baseline	No
Secondary	Time to first or only P. falciparum infection by light microscopy and PCR		8 months post-baseline	No
Secondary	Time to first or only P. ovale infection by light microscopy and PCR		8 months post-baseline	No
Secondary	Time to first or only P. malariae infection by light microscopy and PCR		8 months post-baseline	No