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

Study Overview
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Brief Summary
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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.

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

Conditions
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Malaria

Intervention / Treatment
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* Drug: Pyronaridine-artesunate
* Drug: Artemether-lumefantrine combination


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pyronaridine-artesunate<br>pyronaridine-artesunate: recommended dose according to body weight, once a day for three days. | Drug: Pyronaridine-artesunate<br> <br> * Other names: Pyramax;|
| Active Comparator: Artemether-lumefantrine<br>artemether-lumefantrine: recommended dose according to body weight, twice a day for three days. | Drug: Artemether-lumefantrine combination<br> <br> * Other names: Coartem;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCR-corrected adequate clinical and parasitological response (ACPR) |  | day 28 after initial dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |