Table 2. Primary (cure rates) and secondary clinical endpoints (parasite and fever clearance) for all treatment groups.
Arm | ||||||
Characteristics | 1 | 2 | 3 | P value Arm1 vs Arm 2 | P value Arm1+2 vs 3 | P value Arm 1 vs Arm 2 vs Arm 3 |
Cure rate Day 28 | ||||||
No. of patients evaluable on Day 28 | 45 | 46 | 22 | |||
No. of cured patients | 44 | 46 | 22 | 0.92 | 0.89 | 0.995 |
Cure rate % (95%CI) | 97.8 | 100 | 100 | |||
(87.8–99.8) | (91.1–100) | (83.4–100) | ||||
Treatment failure | 1 | 0 | 0 | 1 | 1 | 0.596 |
Cure rate Day 42 (PCR-corrected) | ||||||
No. of patients evaluable for study end point Day 42 | 42 | 44 | 20 | |||
No. of cured patients | 41 | 43 | 20 | 0.89 | 0.92 | 1 |
Cure rate %(95%CI) | 97.8 | 100 | 100 | |||
(87.8–99.8) | (91.1–100) | (83.4–100) | ||||
Treatment failure | 1 | 1 | 0 | 1 | 1 | 1 |
PCT, h | ||||||
Median (IQR) | 29.8 | 29.5 | 43.1 | |||
(24.3–32.8) | (19.8–32.4) | (33.6–54.8) | 0,327 | <0.001 | <0.001 | |
PCT50 | ||||||
Median (IQR) | 9.3 | 8.5 | 29.5 | 0.542 | 0.002 | 0.006 |
(6.5–18.4) | (7.1–17.5) | (7.1–31.0) | ||||
PCT90 | ||||||
Median (IQR) | 17.6 | 17.4 | 30.0 | 0.905 | <0.001 | 0.003 |
(8.9–19.7) | (8.3–19.5) | (18.2–31.6) | ||||
Parasite reduction ratio | ||||||
Median (IQR) after 12h | 0.93 | 0.78 | 70.37 | 0.610 | <0.001 | <0.001 |
(0.0–2.98) | (0.0–3.08) | (5.71–187.84) | ||||
Median (IQR) after 24h | 0.0 | 0.0 | 0.8 | 0.857 | <0.001 | <0.001 |
(0.0–0.0) | (0.0–0.0) | (0.0–7.14) | ||||
Median (IQR) after 36h | 0.0 | 0.0 | 0.0 | 1 | 0.019 | 0.062 |
(0.0–0.0) | (0.0–0.0) | (0.0–0.57) | ||||
FCT, h | ||||||
Median (IQR) | 17.9 | 19.1 | 29.3 | |||
(4.6–20.7) | (6.6–23.6) | (16.0–43.1) | 0.263 | 0.001 | 0.003 |
NOTE: 95%CI, 95% confidence interval; PCT, parasite clearance time in hours; IQR, interquartile range; PCT50, time in hours to 50% clearance of parasite density; PCT90, time in hours to 90% clearance of parasite density.