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Evaluation of new drug treatments including artemisinin combination therapy for uncomplicated malaria in children in Papua New Guinea

Evaluation of new drug treatments including artemisinin combination therapy for uncomplicated malaria in children in Papua New Guinea

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000550606
Enrollment
600
Registered
2005-09-29
Start date
2005-04-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We aim to assess whether new combination therapies for malaria, based on artemisinin drugs and a chloroquine-like drug piperaquine, will be effective in children with malaria in Papua New Guinea

Interventions

Chloroquine/sulfadoxine/pyrimethamine Dihydroartemisinin-piperaquine Artesunate-piperaquine Chloroquine These drug regimes will be given by mouth in conventional doses over up to three days as treatment for malaria.

Sponsors

University of Western Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
4 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

Children with a history of fever and a blood film positive for either P. falciparum or P. vivax will be eligible provided that: i) they have no features of severe malaria,34 ii) there is no history of prior antimalarial drug use (quinine or artemisinin drugs within 7 days, or a 4-aminoquinoline, pyrimethamine and/or sulphonamide within 28 days), iii) there is no clinical evidence of another infection as a cause of fever, and iv) the childs parents or relatives give informed consent.

Exclusion criteria

No exclusion criteria

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 4, 2026