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

Royal Tropical Institute

Status and phase

Completed

Phase 3

Conditions

Malaria

Treatments

Drug: Artemether-lumefantrine combination

Drug: Pyronaridine-artesunate

Study type

Interventional

Funder types

Other

Identifiers

NCT02411994

KIT601714

Details and patient eligibility

About

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.

Enrollment

197 patients

Sex

All

Ages

6 months to 12 years old

Volunteers

No Healthy Volunteers

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.