CompletedPhase 3Phase 4ACTRN12610000913077

Artesunate-pyronaridine and artemisinin-naphthoquine combination therapies for Papua New Guinean children with uncomplicated malaria infections

Efficacy of artesunate-pyronaridine and artemisinin-naphthoquine combination therapies compared with standard artemether-lumefantrine in children from Papua New Guinea with uncomplicated malaria who are monitored for recurrent malaria over 42 days post-treatment


Sponsor

University of Western Australia

Enrollment

637 participants

Start Date

Apr 2, 2012

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 0 YearssMax Age: 5 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests two newer malaria drug combinations in children in Papua New Guinea. It is for children up to 5 years old with confirmed malaria and fever who do not have signs of severe disease, malnutrition, or other infections.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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).


Locations(3)

Madang, Papua New Guinea

East Sepik, Papua New Guinea

East New Britain, Papua New Guinea

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