A Phase II Pilot Trial to Evaluate CoBaT-Y017 Safety and Efficacy against Uncomplicated Falciparum Malaria versus Artemether-Lumefantrine in Benin Subjects
Table 1
Evolution of the positive thick blood film and the parasite density in the two arms of study at different days of visit.
Biological characteristics
Day
AL group
CoBaT-Y017 group
value
Proportion or mean (± std)
Proportion or mean ( ± std)
Positive thick blood film
D1
100%
100%
D2
75%
46.2%
0.14
D3
33.3%
23.1%
0.67
D4
—
15.4%
D5
—
—
D7
—
—
D14
—
—
D21
—
—
D28
—
—
Parasite density
D1
14482.4 (±7888)
17832.4 (±28442)
0.77
D2
6375.3 (±17689)
4335.5 (±9385)
0.72
D3
172.6 (±352)
1785.2 (±4846.4)
0.26
D4
367.3 ((±1131)
—
D5
—
—
D7
—
—
D14
—
—
D21
—
—
D28
—
—
Fisher’s exact nonparametric test; D4-positive parasitaemia was only observed in the CoBaT-Y017 group; —: negative thick blood film.