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Table 2 Summary of key variables and baseline characteristics of Study 1 and Study 2

From: Safety and efficacy of the choline analogue SAR97276 for malaria treatment: results of two phase 2, open-label, multicenter trials in African patients

Group

Study 1

Study 2

1A

1B

1C

1D

2A

2B

2C

N

34

30

30

19

8

8

4

Benin (n)

0

0

0

2

0

0

0

Burkina Faso (n)

34

24

26

0

4

5

2

Gabon (n)

0

6

4

12

2

2

2

Tanzania (n)

0

0

0

5

0

0

0

Kenya (n)

0

0

0

0

0

1

0

Age (in years)a

39 (18–64)

35 (18–60)

37 (18–63)

9 (7–17)

14 (12–17)

14 (12–16)

13 (12–16)

Body temp. (°C)a

37.1 (35.9–39.4)

37.2 (36.5–38.9)

37.2 (36.3–38.3)

37.6 (36.8–40)

37.2 (36.9–39.9)

38.0 (36.2–40.3)

38.1 (37.0–38.8)

BMI in kg/m2a

21 (15–32)

23 (17–38)

21 (18–31)

16 (12–22)

17 (15–18)

17 (14–23)

18 (14–21)

Parasitemia (parasites/µL)a

688 (112–33,680)

646 (114–67,500)

518 (117–11,920)

44,000 (1115–99,200)

6318 (2105–69,155)

6080 (2016–31,400)

12,811 (2003–28,559)

Hemoglobin (g/L)a

129 (106–146)

117 (94–146)

132 (82–160)

102 (80–127)

112

117

126

Treatment response

20/34 (58.8%)

27/30 (90%)

23/30 (76.6%)

13/19 (68.4%)

0/8 (0%)

3/8 (37.5%)

4/4 (100%)

Patients with any TEAE

18 (52.9%)

18 (60%)

14 (46.7%)

11 (57.9%)

8 (100%)

5 (63%)

1 (25%)

Patients with any serious AE

3 (8.8%)

0

0

1 (5.3%)

4 (50%)

2 (25%)

0

  1. aMedian (Min–Max)
  2. Study 1: Allocation of SAR97276A to the following groups: Group 1A: 1 day IM administration to adults; Group 1B: 3 days IM administration to adults; Group 1C: 1 day IV route to adults, Group 1D: 3 days IM administration to children. Study 2: SAR97276A allocation to the following groups: Group 2A: once daily for 3 days IM administration to teenager; Group 2B: twice daily for 3 days IM administration to teenager. Group 2C: artemether–lumefantrine control treatment to teenager