Table 3.
Adequate clinical and Parasitological response (ACPR) in the intention-to-treat population
| Pyronaridine–artesunate (n = 101) |
Artemether–lumefantrine (n = 96) |
Difference (95% CI) | |
|---|---|---|---|
| Day 28 | |||
| PCR-corrected ACPR, n/Na | 93/101 | 81/96 | |
| % (95% CI) | 92.1 (85.1 to 95.9) | 84.4 (75.8 to 90.3) | 7.7 (− 1.4 to 17.1) |
| Total no. of failures | 8 (7.9) | 15 (15.6) | |
| No. with missing data | 6 (5.9) | 11 (11.5) | |
| No. with early treatment failure | 0 | 0 | |
| No. with late clinical failure | 0 | 0 | |
| No. with late parasitological failure | 1 (1.0) | 3b (3.1) | |
| No. with reinfection < day 28 | 1 (1.0) | 1 (1.0) | |
| Uncorrected ACPR, n/N | 87/101 | 75/96 | |
| % (95% CI) | 86.1 (78.1 to 91.6) | 78.1 (68.9 to 85.2) | 8.0 (− 2.7 to 18.8) |
| Total no. of failures | 14 (13.9) | 21 (21.9) | |
| No. with missing data | 6 (5.9) | 11 (11.5) | |
| No. with early treatment failure | 0 | 0 | |
| No. with late clinical failure | 1 (1.0) | 1 (1.0) | |
| No. with late parasitological failure | 7 (6.9) | 9 (9.4) | |
| Day 42 | |||
| PCR-corrected ACPR, n/Na | 73/101 | 61/96 | |
| % (95% CI) | 72.3 (62.9 to 80.1) | 63.5 (53.6 to 72.5) | 8.7 (− 4.3 to 21.4) |
| Total no. of failures | 28 (27.7) | 35 (36.5) | |
| No. with missing data | 15 (14.9) | 19 (19.8) | |
| No. with early treatment failure | 0 | 0 | |
| No. with late clinical failure | 1 (1.0) | 0 | |
| No. with late parasitological failure | 3b (3.0) | 6c (6.3) | |
| No. with reinfection < day 42 | 9 (8.9) | 10 (10.4) | |
| Uncorrected ACPR, n/N | 67/101 | 56/96 | |
| % (95% CI) | 66.3 (56.7 to 74.8) | 58.3 (48.3 to 67.7) | 8.0 (− 5.5 to 21.1) |
| Total no. of failures | 34 (33.7) | 40 (41.7) | |
| No. with missing data | 15 (14.9) | 19 (19.8) | |
| No. with early treatment failure | 0 | 0 | |
| No. with late clinical failure | 5 (5.0) | 2 (2.1) | |
| No. with late parasitological failure | 14 (13.9) | 19 (19.8) | |
Data are n (%) unless otherwise indicated
aPCR-corrected for reinfection by msp1, msp2 and glurp genotyping
bOne of the late parasitological failures had indeterminate genotyping and was marked as recrudescence
cTwo of the late parasitological failures had indeterminate genotyping and were marked as recrudescence