Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients
Condition: Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this phase III clinical study is to compare the efficacy and safety
      of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of the
      combination of mefloquine plus artesunate (MQ + AS) in children and adults with uncomplicated
      P falciparum malaria in South East Asia, India and Africa.
    

Detailed description: 
      This is a multi-centre, comparative, randomised, open-label, parallel-group, non-inferiority
      study comparing the efficacy and safety of a fixed combination of PA to a loose combination
      of MQ + AS for patients with acute, symptomatic, uncomplicated P. falciparum malaria. The
      study population will include 1271 patients, comprising male and female children (≥20 kg body
      weight) and adults, recruited from study sites in South East Asia, India and Africa. Patients
      will be randomised in a 2:1 ratio to receive either oral PA (180:60mg tablets) or MQ (250mg
      tablets) plus AS (100mg tablets) once a day for 3 consecutive days (Days 0, 1, and 2). The
      study drug will be administered by a Third-Party Investigator unblinded to the study
      treatment, while the Investigator remains blinded.

      Patients will be confined to the to the study facility for ≥4 days (Days 0, 1, 2, and 3) and
      remain near the study site for ≥7 days, or once fever and parasite clearance has been
      confirmed for ≥24 hours - whichever occurs later.

      The primary efficacy end point for the study is the proportion of patients with PCR-corrected
      adequate clinical and parasitological response (ACPR) on Day 28. Scheduled follow-up visits
      will continue until completion of the study at Day 42. In the case of adverse events reported
      and unresolved at Day 42, patients will be followed up for a further 30 days, or until
      resolution of the event.

      The primary efficacy end point for the study is the proportion of subjects with PCR-corrected
      adequate clinical and parasitological response (ACPR) on Day 28 (defined as the absence of
      parasitaemia without the subject's meeting any of the criteria of early treatment failure,
      late clinical failure, or late parasitological failure). Scheduled follow-up visits will
      continue until completion of the study at Day 42. In the case of adverse events reported and
      unresolved at Day 42, patients will be followed up for a further 30 days, or until resolution
      of the event.
    

Intervention name(s): Pyronaridine - artesunate; Mefloquine plus artesunate
Intervention type(s): Drug; Drug
Intervention description(s): once a day for 3 days; once a day for 3 days
Other intervention name(s): Pyramax
Intervention MeSH terms: Artesunate; Mefloquine; Pyronaridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malaria; antimalarial; P falciparum; pyronaridine; artesunate; artemisinin based combination therapy (ACT); pyronaridine artesunate (Pyramax)