Efficacy and Safety of Pyronaridine-Artesunate Versus Artemether-Lumefantrine
Condition: Malaria Fever; Plasmodium Falciparum Malaria; Uncomplicated Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In Nigeria, malaria is the commonest reason for outpatient clinic attendance in childhood and
      is responsible for about 20% of childhood deaths. The emergence of strains of P. falciparum
      resistant to chloroquine and sulfadoxine-pyrimethamine led to severe worsening of morbidity
      and mortality from malaria. As a result of resistance to previously used monotherapy, the
      World Health Organization (WHO) in 2001, recommended that malaria-endemic countries
      experiencing drug-resistant malaria infection adopt combination therapy. Artemisinin-based
      combination therapy (ACT) is preferred to the non-ACT combination. In this randomized
      open-label clinical trial, the safety and efficacy of pyronaridine-artesunate and
      artemether-lumefantrine in the treatment of malaria among children aged 3 to 144 months who
      have microscopically confirmed symptomatic Plasmodium falciparum malaria were compared. The
      study was carried out at the Oni Memorial Children's Hospital, Ring Road Ibadan. One hundred
      and seventy-two children between 3 and 120 months who meet the inclusion criteria will be
      enrolled after obtaining written or witnessed signed informed consent from the parents or
      guardian. A detailed history and physical examination were carried out on each enrollee.
      Finger prick blood samples were taken from each enrolee for thick blood smear for malaria
      parasite, haematocrit, and blood spots on filter paper. Five millilitres of venous blood will
      be taken from an arm vein for baseline liver function tests, creatinine, and random blood
      glucose on days 0, 3, 7 and 28. Enrollees were randomized into one of two groups. Group one
      received pyronaridine-artesunate while group two received artemether-lumefantrine at standard
      doses. Enrollees were seen daily from days 0-3, and on days 7, 14, 21 and 28. Study drugs
      were administered supervised at standard dosage on days 0, 1, and 2. History taking, physical
      examination and blood smears were done at each contact time. Special attention will be paid
      to adverse effects. Parasite clearance time, fever clearance time and cure rates were
      compared between the two groups.
    


Intervention name(s): Antimalarials, pyronaridine-artesunate; Antimalarials, Artemether + Lumefantrine
Intervention type(s): Drug; Drug
Intervention description(s): The main interventions investigated are pyronaridine-artesunate granules or tablets (Pyramax™) manufactured by Shin Poong Pharmaceuticals, Seoul, Korea. Pyramax granules come in sachets with each containing 60mg of pyronaridine/20mg of artesunate while Pyramax tablets contain 180mg pyronaridine/60mg artesunate.; Artemether-lumefantrine dispersible tablets (Coartem™, Novartis pharma) twice daily according to body weights. Each dispersible tablet of AL contains 20mg of artemether/120mg of lumefantrine).
Other intervention name(s): Pyramax™; Coartem™, Novartis pharma
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination; Pyronaridine; Antimalarials; Pyronaridine tetraphosphate, artesunate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study participants were assigned into one of the two treatment groups according to a pre-generated randomization code. Children randomized to Pyramax™ received three doses of pyronaridine-artesunate granules or tablets manufactured by Shin Poong Pharmaceuticals, Seoul, Korea depending on their body weights. Pyramax granules come in sachets with each containing 60mg of pyronaridine/20mg of artesunate while Pyramax tablets contain 180mg pyronaridine/60mg artesunate. Study participants randomized to Coartem™ received the standard six-dose regimen of AL dispersible tablets (Coartem™, Novartis pharma) twice daily according to body weights.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antimalarial; Pyronaridine-artesunate; Artemether-lumefantrine