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A Phase IIIb/IV comparative, randomised, multi-centre, open label, parallel 3-arm clinical study to assess the safety and efficacy of repeated administration of ACT therapy (pyronaridine-artesunate or dihydroartemisinin-piperaquine will be compared to either artesunate-amodiaquine or artemether-lumefantrine)

Trial Profile

A Phase IIIb/IV comparative, randomised, multi-centre, open label, parallel 3-arm clinical study to assess the safety and efficacy of repeated administration of ACT therapy (pyronaridine-artesunate or dihydroartemisinin-piperaquine will be compared to either artesunate-amodiaquine or artemether-lumefantrine)

Status: Completed
Phase of Trial: Phase III/IV

Latest Information Update: 10 Jun 2021

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At a glance

  • Drugs Artesunate/pyronaridine (Primary) ; Dihydroartemisinin/piperaquine (Primary)
  • Indications Falciparum malaria; Malaria
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms WANECAM-EDCTP
  • Most Recent Events

    • 01 Jun 2021 Results (n=552), of a subgroup analysis assessing the persistent sub-microscopic Plasmodium falciparum parasitaemia 72 hours after treatment with artemether-lumefantrine predicts 42-day treatment failure in Mali and Burkina Faso published in the Antimicrobial Agents and Chemotherapy
    • 03 Apr 2018 Primary endpoint (the unadjusted and PCR-adjusted adequate clinical and parasitological response (ACPR) for P falciparum and unadjusted ACPR for other Plasmodium species (ie, P ovale and P malariae) at days 28 and 42) has been met, according to results published in the lancet journal.
    • 03 Apr 2018 Primary endpoint (The incidence rate of malaria and repeated treatment safety over 2 years) has been met, according to results published in the lancet journal.

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