Trial | NCT02411994  Report issue

Title

Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Malaria
Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Uncomplicated Falciparum Malaria in Western Kenya

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    197
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.
Study Started
Oct 31
2015
Primary Completion
Aug 31
2017
Study Completion
Aug 31
2017
Last Update
Nov 27
2017

Drug Pyronaridine-artesunate

  • Other names: Pyramax

Drug Artemether-lumefantrine combination

  • Other names: Coartem

Pyronaridine-artesunate Experimental

pyronaridine-artesunate: recommended dose according to body weight, once a day for three days.

Artemether-lumefantrine Active Comparator

artemether-lumefantrine: recommended dose according to body weight, twice a day for three days.

Criteria 

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.
No Results Posted