Study design |
Author (year) |
Country | Patient selection | Sample size (per protocol pop.) | Length of follow‐up (days) | Trial sponsor | Baseline liver function tests? | Excluded participants with raised liver enzymes |
Single arm | Bui 2020 | Vietnam | Adults + children | 155 | 42 | BMG USAID | Yes | Yes |
Han 2020 | Myanmar | Adults + children (≥ 6 years) | 390 | 42 | BMG USAID | No | No | |
Leang 2016 | Cambodia | Adults + children | 117 | 42 | BMG | No | Yes | |
Leang 2019a | Cambodia | Adults + children (≥ 7 years) | 224 | 42 | BMG USAID | No | Yes | |
Leang 2019b | Cambodia | Adults + children (≥ 7 years) | 121 | 42 | BMG | No | Yes | |
Cohort event monitoring | Lutete 2021a | Cameroon, Democratic Republic of the Congo, Gabon, Côte D'Ivoire, Republic of the Congo | Adults + children | 7746 | 28 | MMV | Yes | No |
Dose escalation | Ramharter 2008 | Gabon | Children (2 to 14 years) | 59 | 42 | MMV Shin Poong Pharma | Yes | Yes |
All studies used Pyramax as the study drug, which was supplied by Shin Poong Pharmaceuticals. All studies used a dose of 180 mg pyronaridine plus 60 mg artesunate, except Ramharter 2008, which was a dose‐escalation study using four doses: 48 mg of pyronaridine tetraphosphate and 16 mg of artesunate; 72 mg of pyronaridine tetraphosphate and 24 mg of artesunate; 96 mg of pyronaridine tetraphosphate and 32 mg of artesunate; 60 mg of pyronaridine tetraphosphate and 20 mg of artesunate. Abbreviations: BMG: Bill & Melinda Gates Foundation; MMV: Medicines for Malaria Venture. |