|
Variables
|
|
PCR corrected efficacy outcome—no. (%)
|
|
Per protocol population (N = 420) n (%)
|
213
|
207
|
–
|
–
|
|
Adequate clinical and parasitological response
|
194 (91.1)
|
203 (98.1)
|
− 7 (− 11.0 to − 2.7)
|
< 0.0006
|
|
Early treatment failure
|
0 (0.0)
|
0 (0)
|
–
|
–
|
|
Late clinical failure
|
0 (0.0)
|
0 (0)
|
–
|
–
|
|
Late parasitological failure
|
19 (8.9)
|
4 (1.9)
|
–
|
–
|
|
Total number of failure
|
19 (8.9)
|
4 (1.9)
|
–
|
–
|
|
Not corrected for reinfection n (%)
|
|
Adequate clinical and parasitological response
|
106 (49.8)
|
147 (71.0)
|
− 22 (− 31.1 to − 12.9)
|
< 0.0001
|
|
Early treatment failure
|
0 (0)
|
0 (0)
|
–
|
–
|
|
Late clinical failure
|
32 (15.0)
|
22 (10.6)
|
–
|
–
|
|
Late parasitological failure
|
75 (35.2)
|
38 (18.4)
|
–
|
–
|
|
Total number of failure
|
107 (50.2)
|
60 (28.9)
|
–
|
–
|
|
Intent-to-treat population (N = 440)
|
220
|
220
|
–
|
–
|
|
PCR-adjusted
|
|
Total number of patients n
|
194
|
203
| | |
|
Adequate clinical and parasitological response % (95% CI)
|
88.2 (83.2–91.8
|
92.3 (87.9–95.2)
|
− 4.1 (− 9.8 to − 1.5)
|
0.148
|
|
PCR-unadjusted
|
|
Total number of patients n
|
106
|
147
|
–
|
–
|
|
Adequate clinical and parasitological response % (95% CI)
|
48.2 (41.6–54.8)
|
66.8 (60.3–72.8)
|
− 18.6 (− 27.4 to 9.4)
|
< 0.001
|
