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Table 3 Treatment outcome among patients with uncomplicated malaria treated with Artemether–lumefantrine or Pyronaridine–artesunate in Ibadan, southwest Nigeria

From: Efficacy and safety of pyronaridine–artesunate versus artemether–lumefantrine in the treatment of acute uncomplicated malaria in children in South-West Nigeria: an open-labelled randomized controlled trial

Treatment outcome

Artemether–lumefantrine

Pyronaridine–artesunate

Total

ρ-value

N (%)

N (%)

N (%)

TOTAL enrolled

87 (100)

85 (100)

172 (100)

 

Completed study

83 (95.4)

82 (96.5)

165 (95.9)

0.535

LTFU

3 (3.4)

2 (2.4)

5 (2.9)

Withdrawn

1 (1.2)

0 (0.0)

1 (0.6)

Withdrawal of consent

0 (0.0)

1 (1.2)

1 (0.6)

ITT-uncorrected

N = 87 (100)

N = 85 (100)

N = 172 (100)

 

ACPR—D28

59 (67.8)

76 (89.4)

135 (78.5)

0.001

Treatment failure

24 (27.6)

6 (7.1)

30 (17.4)

LTFU/withdrawn

4 (4.6)

3 (3.5)

7 (4.1)

PP—uncorrected

N = 83

N = 82

N = 165

 

ACPR—D21

73/83 (88.0)

82/83 (98.8)

135/166 (93.4)

0.016

ACPR—D28

59/83 (71.1)

76/82 (92.7)

135/165 (81.8)

 

LPF—D28

17 (20.5)

6 (7.3)

23 (13.9)

0.001

LCF—D28

7 (8.4)

0 (0.0)

7 (4.2)

PP-PCR corrected

N = 67

N = 78

N = 145

 

Cure rate—D28

59 (88.1)

76 (97.4)

135 (93.1

0.04

Recrudescence

8 (11.9)

2 (2.6)

9 (6.9)

Day of failure [N (%)]

24 (110)

6 (100)

30 (100)

 

Day 14

2 (8.3)

0 (0.0)

2 (6.7)

 

Day 21

9 (37.5)

1 (16.7)

10 (33.3)

0.405

Day 28

13 (54.2)

5 (83.3)

18 (60.0)

% Failed before D28

11 (45.8)

1 (16.7)

12 (40.0)

 

% Failed on D28

13 (54.2)

5 (83.3)

18 (60.0)

0.358

Parasite clearance time (days)

    

 Mean ± SD

2.15 ± 0.68

2.08 ± 0.64

2.12 ± 0.66

0.430

 Range

1–4

1–3

1–4

Fever clearance time (days)

    

 Mean ± SD

1.11 ± 0.32

1.13 ± 0.44

1.13 ± 0.38

0.664

 Range

1–2

1–3

1–3

Haematocrit at D28 (in %)

    

 Mean ± SD

33.3 ± 2.95

34.9 ± 2.79

34.13 ± 2.95

0.002

 Range

23–40

28–42

25–42

Haematocrit < 30% D28

1 (1.4)

1 (1.4)

2 (1.4)

1.000

  1. PP per-protocol population, ITT intent-to-treat population, ACPR adequate clinical and parasitological cure, LTF late treatment failure, LCF late clinical failure, LTFU lost to follow up