Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Malaria

Overview

The purpose of this study is to determine the efficacy of pyronaridine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children.

Full Title of Study: “Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Uncomplicated Falciparum Malaria in Western Kenya”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2017

Interventions

  • Drug: Pyronaridine-artesunate
  • Drug: Artemether-lumefantrine combination

Arms, Groups and Cohorts

  • Experimental: Pyronaridine-artesunate
    • pyronaridine-artesunate: recommended dose according to body weight, once a day for three days.
  • Active Comparator: Artemether-lumefantrine
    • artemether-lumefantrine: recommended dose according to body weight, twice a day for three days.

Clinical Trial Outcome Measures

Primary Measures

  • PCR-corrected adequate clinical and parasitological response (ACPR)
    • Time Frame: day 28 after initial dose

Secondary Measures

  • PCR-corrected adequate clinical and parasitological response (ACPR)
    • Time Frame: day 42 after initial dose
  • crude adequate clinical and parasitological response (ACPR)
    • Time Frame: day 28, day 42 after initial dose
  • parasite clearance time
    • Time Frame: up to 7 days after initial dose
  • gametocyte clearance time
    • Time Frame: up to 7 days after initial dose
  • transmission potential to mosquitos
    • Time Frame: day 7 after initial dose

Participating in This Clinical Trial

Inclusion Criteria

  • Children between 6 months and 12 years old, with a body weight of ≥5 kg; – Living in the catchment area of the study (within a radius of ~10 km from St. Jude's Clinic, Mbita, Kenya); – Having microscopically confirmed P. falciparum mono-infection (asexual parasite density 1,000-200,000 µL-1). Exclusion Criteria:

  • Signs and symptoms of severe malaria (according to WHO criteria for severe malaria, (WHO 2012)) or any other severe illness necessitating parenteral treatment; – Mixed Plasmodium infection; – Clinically suspected (oedema, jaundice and/or ascites) or reported hepatic and/or renal impairment (any cause, as reported by parents/guardians and/or evident from medical history); – Having anaemia with an Hb <6 g/dL; – Evidence of severe malnutrition (severe wasting: z-score weight for age <-3 and severe stunting: z-score height for age <-3 (WHO 2009b)); – Having received anti-malarial therapy in the previous two weeks; – Known history of hypersensitivity, allergic or adverse reactions to artesunate, artemether-lumefantrine or other artemisinins; – Participating in other anti-malarial drug intervention studies; – Previous participation in the PAAL study, e.g. in the previous transmission season (each individual child can only take part in this study once); – Not being available for follow-up.

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Royal Tropical Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Patrick Sawa, MD, PhD, Principal Investigator, International Centre of Insect Physiology and Ecology (ICIPE)

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