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

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Tropical Institute
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artesunate; Lumefantrine; Pyronaridine

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.