Table 2.
Primary and secondary end points
| End point | AL (n=63) | AS + AQ (n=57) | P-value |
|---|---|---|---|
| Primary end pointa | |||
| Parasite clearance rate (n)b | 55 | 54 | |
| Lag phase (hours), (n); median (range) | (29); 6.0 (6–12) | (31); 6.0 (6–12) | 0.77 |
| Parasite clearance rate constant(per hour), median (IQR) | 0.29 (0.24–0.37) | 0.31 (0.26–0.40) | 0.17 |
| Slope half-life (hours), median (IQR) | 2.36 (1.85–2.88) | 2.23 (1.74–2.63) | 0.20 |
| PCT (hours), n | 55 | 54 | |
| PCT, median (IQR) | 30.0 (24.0–36.0) | 30.0 (24.0–36.0) | 0.22 |
| PC50, median IQR) | 8.93 (4.37–11.84) | 7.95 (4.65–10.46) | 0.77 |
| PC90, median (IQR) | 14.34 (10.58–17.78) | 14.02 (10.65–17.10) | 0.51 |
| PC95, median (IQR) | 16.65 (13.11–20.69) | 16.0 (12.78–19.69) | 0.44 |
| PC99, median (IQR) | 22.19 (18.75–25.84) | 21.32 (18.46–25.07) | 0.34 |
| Secondary end points | |||
| Treatment outcomes, n | 63 | 57 | |
| LPF (PCR corrected), n | 01 | 00 | 1 |
| PCR-corrected cure rate (K–M) | |||
| At day 28, n (%) (95% CI) | 63 (100) | 57 (100) | 1 |
| At day 42, n (%) (95% CI) | 62 (98.07) (88.07–99.67) | 57 (100) | 1 |
| FCT (hours), (n); median (IQR) | (63); 6 (6–6) | (57); 6 (6–6) | 0.49 |
Notes:
a
PC50, 50% parasite clearance rate; PC90, 90% parasite clearance rate; PC95, 95% parasite clearance rate; PC99, 99% parasite clearance rate.
b
As estimated by the PCE (WWARN).
Abbreviations: AL, artemether + lumefantrine; AS + AQ, artesunate + amodiaquine; FCT, fever clearance time; K–M, Kaplan–Meier; LPF, late parasitological failure; PCE, parasite clearance estimator; PCR, polymerase chain reaction; PCT, parasite clearance time; WWARN, Worldwide Antimalarial Resistance Network.