Malaria
Conditions
Brief 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.
Interventions
Sponsors
Royal Tropical Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCR-corrected adequate clinical and parasitological response (ACPR) | day 28 after initial dose |
Secondary
| Measure | Time frame |
|---|---|
| PCR-corrected adequate clinical and parasitological response (ACPR) | day 42 after initial dose |
| crude adequate clinical and parasitological response (ACPR) | day 28, day 42 after initial dose |
| parasite clearance time | up to 7 days after initial dose |
| gametocyte clearance time | up to 7 days after initial dose |
| transmission potential to mosquitos | day 7 after initial dose |
Countries
Kenya
Outcome results
None listed