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Table 2 Treatment outcomes on day 28, according to study cohort (AL or ASAQ) at various sites in Mozambique

From: In vivo efficacy of artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated falciparum malaria in children: a multisite, open-label, two-cohort, clinical trial in Mozambique

 

Study site

 

Cohort 1: Artemether-Lumefantrine

Montepuez

Dondo

Chokwe

Manhiça

Tete

TOTAL

Variable

N = 88

N = 88

N = 86

N = 89

N = 88

N = 439

ACPRa (uncorrected) n

65

70

70

62

68

335

ETFb n

0

0

1

0

0

1

LCFc n

4

4

0

0

0

8

LPFd n

9

6

6

5

4

30

New infections (with PCR) n

9

7

4

3

2

25

Recrudescences (with PCR) n

4

3

2

2

2

13

No treatment outcome (loss to follow-up or withdrawn) n

10

8

9

22

16

66

PPe day-28 efficacy (PCR-uncorrected) n/N (95%CI)

65/78 (83.3) [73.2-90.8]

70/80 (87.5) [78.2-93.8]

70/77 (90.9) [82.2-96.3]

62/67 (92.5) [83.4-97.5]

68/72 (94.4) [86.4-98.5]

335/374 (89.6) [86.0-92.5]

PP day-28 efficacy (PCR-corrected) n/N (95%CI)

65/69 (94.2) [85.8-98.4]

70/73 (95.9) [88.5-99.1]

70/73 (95.9) [88.5-99.1]

62/64 (96.9) [89.2-99.6]

68/70 (97.) [90.1-99.7]

335/349 (96.0) [93.4-97.8]

Cohort 2: Artesunate-amodiaquine

Montepuez

Dondo

Chokwe

Manhiça

Tete

TOTAL

Variable

N = 87

N = 87

N = 87

N = 0

N = 0

N = 261

ACPRa (uncorrected) n

81

78

73

NA

NA

232

ETFb n

0

0

0

NA

NA

0

LCFc n

0

0

0

NA

NA

0

LPFd n

0

0

1

NA

NA

1

New infections (with PCR) n

0

0

0

NA

NA

0

Recrudescences (with PCR) n

0

0

1

NA

NA

1

No treatment outcome (loss to follow up or withdrawn) n

6

9

13

NA

NA

28

PP day-28 efficacy (PCR-uncorrected) n/N (95%CI)

81/81 (100) [NA]

78/78 (100) [NA]

73/74 (98.6) [92.7-99.9]

NA

NA

232/233 (99.6) [97.6-99.9]

PP day-28 efficacy (PCR-corrected) n/N (95%CI)

81/81 (100) [NA]

78/78 (100) [NA]

73/74 (98.6) [92.7-99.9]

NA

NA

232/233 (99.6) [97.6-99.9]

  1. aACPR:adequate clinical and parasitological response; bETF: early treatment failure; cLCF: late clinical failure; dLPF: late parasitological failure; ePP: per protocol; NA: not applicable.