None listed
Conditions
Brief summary
We recently found that the WHO-recommended combination antimalarial therapy artemether-lumefantrine and the candidate regimen dihydroartemisinin-piperaquine were not fully effective for both falciparum and vivax malaria in young Papua New Guinean children, a group at high risk of complications and death. We plan to study two new combinations (artesunate-pyronaridine and artemisinin-naphthoquine) in the hope that at least one will prove superior and be used in treatment programs in PNG and similar countries.
Interventions
Artesunate-pyronaridine (Pyramax) as artesunate 3 mg/kg and pyronaridine base 10 mg/kg once-daily for three days or artemisinin-naphthoquine (Arco) as artemisinin 20 mg/kg and naphthoquine phosphate 8 mg/kg once-daily for three days. Both drug regimens will be given orally with water. Doses will be calculated from body weight to the nearest whole sachet of granules (Pyramax) or tablets (Arco).
Sponsors
University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 5 Years
Healthy volunteers
No
Inclusion criteria
Children with an axillary temperature >37.5 degrees Centigrade or fever during the previous 24 hours with either P. falciparum (>1000 asexual parasites per microlitre whole blood) or P. vivax (>250 per microlitre) on blood smear microscopy
Exclusion criteria
Features of severity, treatment with a study drug or other antimalarial in the previous 28 days, clinical or laboratory evidence of another infection or co-morbidity including malnutrition
Outcome results
None listed