Table 1. Characteristics of included studies.
| Study reference | Ndiaye and colleagues 2011 [38] | Ogutu and colleagues 2014 [22] | Siqueira and colleagues 2017 [21] | WANECAM 2018 [23] |
|---|---|---|---|---|
| Country | Senegal | Kenya | Brazil | Burkina Faso (2 sites), Guinea (1 site), Mali (3 sites) |
| Trial population (with ECG monitoring) | Adults and children (ECG monitoring if age ≥12 years) | Adults (all) | Adults and children (ECG monitoring if age >10 years) | Adults and children (all) |
| Treatment indication | Uncomplicated P. falciparum malaria | Uncomplicated P. falciparum malaria | Uncomplicated P. vivax malaria | Uncomplicated P. falciparum malaria |
| Days of follow-up | 28 | 28 | 42 | 42 |
| Amodiaquine-containing drugs (manufacturer) | ASAQ (Sanofi) | ASAQ (Sanofi) and AQ + AS (Sanofi + Guilin) | ASAQ (Sanofi) | ASAQ (Sanofi) |
| Non-amodiaquine drugs (manufacturer) | AL (Novartis) | None | CQ (Farmanguinhos) | AL (Novartis), DP (Sigma Tau), PA (Shin Poong) |
| Directly observed therapy | All doses | All doses | All doses | All doses |
| Number of participants in amodiaquine drug arms (with ECG monitoring) | 184 (77) | 54 (54) | 189 (179) | 1,061 (417) |
| Number of participants in non-amodiaquine drug arms (with ECG monitoring) | 182 (77) | 0 | 190 (175) | 3,649 (1,708) |
| TdP risk factors excluded at screening | Yes | Yes | No | Yes |
| PK sampling (food intake) | No | Yes (starved) | No | No |
| Vital sign measurement time points, protocol days | 0 (pre-dose), 1, 2, 3, 7, 14, 28 | 0 (pre-dose), 1, 2, 3, 7, 14, 21, 28 | 0 (pre-dose), 1, 2, 3, 7, 14, 28, 42 | 0 (pre-dose), 1, 2, 3, 7, 14, 28, 35, 42 |
| ECG measurement time points, protocol days | 0 (pre-dose), 3 (post-dose) |
0 (pre-dose, +2 hours, +4 hours), 2 (+2 hours, +4 hours), 28 |
0 (pre-dose), 2 (post-dose), 28 |
0 (pre-dose), 2 (+2 to +4 hours) |
| PK sampling time points, protocol days | None | 0 (pre-dose, +0.25 to +4 hours), 1 (+0.25 to +4 hours), 2 (+0.25 to +4 hours), 7, 14, 21, 28 | None | None |
AL, artemether–lumefantrine fixed-dose combination; AQ + AS, artesunate + amodiaquine non-fixed dose combination; ASAQ, artesunate–amodiaquine fixed-dose combination; CQ, chloroquine; DP, dihydroartemisinin–piperaquine fixed-dose combination; ECG, electrocardiogram; PA, pyronaridine–artesunate fixed-dose combination; PK, pharmacokinetic; TdP, torsades de pointes; WANECAM, West African Network for Clinical Trials of Antimalarial Drugs.