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Table 3 Adequate clinical and Parasitological response (ACPR) in the intention-to-treat population

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

 

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)

 
  1. Data are n (%) unless otherwise indicated
  2. aPCR-corrected for reinfection by msp1, msp2 and glurp genotyping
  3. bOne of the late parasitological failures had indeterminate genotyping and was marked as recrudescence
  4. cTwo of the late parasitological failures had indeterminate genotyping and were marked as recrudescence