Table 1 Summary of pyronaridine-artesunate Phase II/III randomized clinical trials included in the integrated analysis
Protocol | SP-C-002-05 | SP-C-003-05 [[24]] | SP-C-004-06 [[15]] | SP-C-005-06 [[25]] | SP-C-007-07 [[22]] | SP-C-006-06 [[23]] |
|---|---|---|---|---|---|---|
Phase | II | II | III | III | III | III |
Region/country | SE Asia, Africa | Gabon | SE Asia, India, Africa | Africa, SE Asia | Africa, SE Asia | SE Asia, India |
Year | 2005–2006 | 2006 | 2007–2008 | 2007–2008 | 2007–2008 | 2007–2008 |
Design | DB/MC/DF | OL/DF | OL/MC/CM | DB/DD/MC/CM | OL/MC/CM | DB/DD/MC/CM |
Pathogen | P. falciparum | P. falciparum | P. falciparum | P. falciparum | P. falciparum | P. vivax |
Parasite counta, μL-1 | 1000–100,000 | 1000–200,000 | 1000–100,000 | 1000–100,000 | 1000–200,000 | ≥250 |
Patient age, years | 15–60 | 2–14 | 3–60 | 3–60 | ≤12 | 3–60 |
Patient weight, kg | 35–75 | 10–40 | 20–90 | 20–90 | ≥5– <25 | 20–90 |
PA target doseb, mg/kg/day | 6:2, 9:3, 12:4 | 6:2, 9:3, 12:4 Granule: 9:3 | 7.2:2.4–13.8:4.6 | 7.2:2.4–13.8:4.6 | 6.7:2.2–13.3:4.4 | 7.2:2.4–13.8:4.6 |
PA dose form | Tablet | Tablet and granule | Tablet | Tablet | Granule | Tablet |
Comparator | – | – | MQ + AS | AL | ALb | CQ |