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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02143934
• Date of registration: 19/05/2014
• Prospective Registration: No
• Primary sponsor: Papua New Guinea Institute of Medical Research
• Public title: Effect of Liver and Blood-stage Treatment on Subsequent Plasmodium Reinfection and Morbidity
• Scientific title: Host and Parasites Factors Contributing to Risk of Plasmodium Re-infection and Morbidity in Elementary School Children in Maprik, East Sepik Province
• Date of first enrolment: August 2009
• Target sample size: 524
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02143934
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
• Phase: Phase 4

Countries of recruitment

Papua New Guinea

Contacts

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

• Name: Inoni Betuela, MD PhD
• Affiliation: PNG Institute of Medical Research

• Name: Louis Schofield, PhD
• Affiliation: Walter and Eliza Hall Institute of Medical Research

Key inclusion & exclusion criteria

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.



Age minimum: 5 Years
Age maximum: 10 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Plasmodium Vivax Clinical Episode

Plasmodium Falciparum Infection

Plasmodium Vivax Infection

Plasmodium Falciparum Clinical Episode

Intervention(s)

Drug: Placebo

Drug: Artemether Lumefantrine

Drug: Primaquine

Drug: Chloroquine

Primary Outcome(s)

Time to first or only clinical P. vivax episode [Time Frame: 8 months post-baseline]

Time to first or only Plasmodium vivax infection by light microscopy and PCR [Time Frame: 8 months post-baseline]

Secondary Outcome(s)

Time to first or only P. ovale infection by light microscopy and PCR [Time Frame: 8 months post-baseline]

Time to first or only P. falciparum infection by light microscopy and PCR [Time Frame: 8 months post-baseline]

Time to first or only P. malariae infection by light microscopy and PCR [Time Frame: 8 months post-baseline]

Secondary ID(s)

07200734

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Swiss Tropical & Public Health Institute

Walter and Eliza Hall Institute of Medical Research

Barcelona Centre for International Health Research