Table 2.
Treatment outcomes on day 28, according to study cohort (AL or ASAQ) at various sites 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No treatment outcome (loss to follow-up or withdrawn) n |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No treatment outcome (loss to follow up or withdrawn) n |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] |
aACPR:adequate clinical and parasitological response; bETF: early treatment failure; cLCF: late clinical failure; dLPF: late parasitological failure; ePP: per protocol; NA: not applicable.