Pyronaridine–artesunate and artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a randomized controlled non-inferiority trial

Table 2 Adequate clinical and parasitological response (ACPR) in the per-protocol population

	Pyronaridine–artesunate	Artemether–lumefantrine	Difference (95% CI)
Day 28
PCR-corrected ACPR, n/N^b	93/94	81/84
% (95% CI)	98.9 (94.2 to 99.8)	96.4 (90.0 to 98.8)	2.5 (− 2.8 to 9.0)^a
Total no. of failures	1 (1.1)	3 (3.6)
No. with early treatment failure	0	0
No. with late clinical failure	0	0
No. with late parasitological failure	1 (1.1)	3^c (3.6)
No. with missing data	7 (7.4)	12 (14.3)
Uncorrected ACPR, n/N	87/95	75/85
% (95% CI)	91.6 (84.3 to 95.7)	88.2 (79.7 to 93.5)	3.3 (− 5.7 to 12.8)
Total no. of failures	8 (8.4)	10 (11.8)
No. with early treatment failure	0	0
No. with late clinical failure	1 (1.1)	1 (1.2)
No. with late parasitological failure	7 (7.4)	9 (10.6)
No. with missing data	6 (6.4)	11 (12.9)
Day 42
PCR-corrected ACPR, n/N^b	73/77	61/67
% (95% CI)	94.8 (87.4 to 98.0)	91.0 (81.8 to 95.8)	3.8 (− 5.1 to 13.5)
Total no. of failures	4 (5.2)	6 (9.0)
No. with early treatment failure	0	0
No. with late clinical failure	1 (1.3)	0
No. with late parasitological failure	3^c (3.9)	6^d (9.0)
No. with missing data	24 (31.2)	29 (43.3)
Uncorrected ACPR, n/N	67/86	56/77
% (95% CI)	77.9 (68.1 to 85.4)	72.7 (61.9 to 81.4)	5.2 (− 8.0 to 18.4)
Total no. of failures	19 (22.1)	21 (27.3)
No. with early treatment failure	0	0
No. with late clinical failure	5 (5.8)	2 (2.6)
No. with late parasitological failure	14 (16.3)	19 (24.7)
No. with missing data	15 (17.4)	19 (24.7)

Data are n (%) unless otherwise indicated
Participants with a reinfection before day 28 were included in the day-28 per-protocol population for the uncorrected analysis. In the PCR-corrected analysis, however, patients with a reinfection before day 28 were excluded from the analysis because data were missing on day 28 (and there was no established recrudescence). On day 42, the per-protocol population was defined similarly
^aNon-inferiority of pyronaridine–artesunate to artemether–lumefantrine is demonstrated if the lower limit of the 95% confidence interval (CI) of the difference in ACPR is > − 7%
^bPCR-corrected for reinfection by msp1, msp2 and glurp genotyping
^cOne of the late parasitological failures had indeterminate genotyping and was marked as recrudescence
^dTwo of the late parasitological failures had indeterminate genotyping and were marked as recrudescence

ISSN: 1475-2875