Table 4.
Characteristic | 2011 (n = 21) | 2015 (n = 27) | P value* |
---|---|---|---|
Parasite clearance time (PCT100) | |||
Median (IQR) [hours] | 36 (30,42) | 96 (54, NA) | <0.001 |
Proportion with PCT > 72 h | 0% (0/21) | 55% (15/55) | |
Parasite clearance half- life T1/2 [hours] | |||
Median (IQR) | 1.97 (1.66, 2.59) | 6.88 (2.84, 7.74) | <0.001 |
Geometric mean (95% CI) | 2.19 (1.86, 2.59) | 5.19 (4.07, 6.62) | |
T1/2 > 5 h | 0/21 (0%) | 18/26 (69%) | |
Fever clearance time [hours] | |||
Median (IQR) [hours] | 30 (18.30) | 36 (24.54) | 0.001 |
Treatment outcome (WHO) | |||
APCR# | 17/21 (81%) | 24/27 (89%) | – |
Early treatment failure | 0/21 (0%) | 0/27 (0%) | |
Clinical treatment failure | 0/21 (0%) | 0/27 (0%) | |
Parasitological treatment failure | 0/21 (0%) | 2/27 (7%) | |
Withdrawal | 2/21 (10%) | 0/27 (0%) | |
Loss to follow-up | 2/21 (10%) | 1/27 (4%) | |
Risk of failure [PCR-uncorrected] | |||
Uncorrected Kaplan–Meier estimate (ITT) | 0% | 8% | 0.22 |
Uncorrected proportion (per protocol) | 0/17 (0%) | 2/26 (8%) | 0.22 |
Risk of failure [PCR-corrected] | |||
Corrected Kaplan–Meier estimate (ITT) | 0% | 0% | – |
Corrected proportion (per protocol) | 0/17 (0%) | 0/24 (0%) | – |
K13-propeller mutation | 0/20 (0%) | C580Y:18/27 (67%) Y493H:2/27 (7%) Total 20/27 (74%) |
<0.001 |
* P values are based on linear trend tests
APCR adequate clinical and parasitological responses