TABLE 2.
Study endpoints
| Endpointa | Value [no./total (%) or median (IQR)] |
|---|---|
| Primary | |
| ACPR | |
| Day 28 | 66/66 (100.0) |
| Day 42 | 49/65 (75.4) |
| Treatment failure (day 42) | |
| LCF | 3/65 (4.6) |
| LPF | 13/65 (20.0) |
| Time to recurrence (days) | 42 (35–42) |
| Secondary | |
| PCT, hours (n = 66) | 48.3 (36.8–60.1) |
| PC1/2, hours (n = 63) | 4.1 (3.5–5.4) |
| Patients with asexual parasitemia at: | |
| Day 1 | 56/67 (83.6) |
| Day 2 | 25/67 (37.3) |
| Day 2, qPCR corrected | 28/63 (44.4) |
| Day 3 | 2/66 (3.0) |
| Day 3, qPCR corrected | 9/65 (13.9) |
| Patients with gametocytes at: | |
| Day 1 | 29/67 (43.3) |
| Day 2 | 8/67 (11.9) |
| Day 2, RT-qPCR corrected | 27/68 (46.6) |
| Day 3 | 0/66 (0) |
| Day 3, RT-qPCR corrected | 7/62 (11.3) |
| No. with severe anemia (Hb < 7 g/dl; day 7) | 0/34 (0) |
a
ACPR, adequate clinical and parasitological response; LCF, late clinical failure; LPF, late parasitological failure; PCT, parasite clearance time; PC1/2, parasite clearance half-life, i.e., time to decrease initial parasitemia by half in log-linear phase; Hb, hemoglobin.