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Table 3 Adequate clinical and parasitological response (ACPR) in the intent-to-treat population

From: Pyronaridine-artesunate granules versus artemether-lumefantrine crushed tablets in children with Plasmodium falciparum malaria: a randomized controlled trial

Outcome

Pyronaridine-artesunate

Artemether-lumefantrine

Difference (95% CI);

P valuea

Day-28 PCR-corrected ACPR,b n/N

333/355

167/180

 

  % (95% CI)

93.8 (90.8–96.1)

92.8 (88.0–96.1)

1.0 (–3.2 to 6.2); P = .65

  P value (exact binomial test)c

0.0077

NC

 

  Total failures

22 (6.2)

13 (7.2)

 

   Early treatment failure

2 (0.6)

0

 

   Late clinical failure

2 (0.6)

0

 

   Late parasitological failure

6 (1.7)

2 (1.1)

 

   Missing = failure

10 (2.8)

6 (3.3)

 

   Re-infection before day 28

2 (0.6)

5 (2.8)

 

Day-28 crude ACPR, n/N

308/355

151/180

 

  % (95% CI)

86.8 (82.8–90.1)

83.9 (77.7–88.9)

2.9 (–3.2 to 9.7); P = .37

  Total failures

47 (13.2)

29 (16.1)

 

   Early treatment failure

2 (0.6)

0

 

   Late clinical failure

6 (1.7)

4 (2.2)

 

   Late parasitological failure

29 (8.2)

19 (10.6)

 

   Missing = failure

10 (2.8)

6 (3.3)

 

Day-42 PCR-corrected ACPR,b n/N

271/355

140/180

 

  % (95% CI)

76.3 (71.6–80.7)

77.8 (71.0–83.6)

–1.4 (–8.6 to 6.4); P = .71

  Total failures

84 (23.7)

40 (22.2)

 

   Early treatment failure

2 (0.6)

0

 

   Late clinical failure

2 (0.6)

0

 

   Late parasitological failure

15 (4.2)

6 (3.3)

 

   Missing = failure

12 (3.4)

6 (3.3)

 

   Re-infection before day 42

53 (14.9)

28 (15.6)

 

Day-42 crude ACPR, n/N

264/355

136/180

 

  % (95% CI)

74.4 (69.5–78.8)

75.6 (68.6–81.6)

–1.2 (–8.6 to 6.8); P = .77

  Total failures

91 (25.6)

44 (24.4)

 

   Early treatment failure

2 (0.6)

0

 

   Late clinical failure

14 (3.9)

5 (2.8)

 

   Late parasitological failure

63 (17.7)

33 (18.3)

 

   Missing = failure

12 (3.4)

6 (3.3)

 
  1. NC, not calculated. Values are n (%) unless otherwise indicated.
  2. a Non-inferiority of pyronaridine-artesunate to artemether-lumefantrine is concluded if the lower limit of the 95% CI for the difference is > –10%. Two-sided Chi-square test for superiority was performed only when non-inferiority was demonstrated.
  3. b Corrected for re-infection using polymerase chain reaction (PCR) genotyping.
  4. c For the hypothesis that the ACPR in the pyronaridine-artesunate group is ≤90%.
  5. Note: There were no instances of indeterminate PCR results in the intent-to-treat population.