Table 2 Gametocyte carriage during follow-up

Study Phase A (asymptomatic parasite carriers)

AL

AL + 0.25 mg/kg PQ

AL + 0.40 mg/kg PQ

P-values

P-values

% (n/N)

% (n/N)

% (n/N)

(AL vs.AL + 0.25 mg/kg PQ)

(AL vs.AL + 0.40 mg/kg PQ)

 Day 0

17.7 (11/62)

32.0 (24/75)

20.5 (15/73)

0.08

0.83

 Day 2

12.9 (8/62)

16.4 (12/73)

13.7 (10/73)

0.63

1.00

 Day 3

9.8 (6/61)

22.9 (16/70)

14.3 (10/70)

0.06

0.59

 Day 7

6.7 (4/60)

4.2 (3/72)

0.0 (0/71)

0.70

0.04

 Day 10

3.3 (2/60)

1.4 (1/71)

0.0 (0/71)

0.60

0.21

 Day 14

0.0 (0/58)

0.0 (0/73)

0.0 (0/71)

-

-

 Day 0

96.4 (54/56)

92.9 (65/70)

85.5 (53/62)

0.46

0.06

 Day 7

46.3 (25/54)

20.3 (14/69)

16.4 (11/67)

0.003

0.001

Study Phase B (patent gametocyte carriers at screening)

AL

AL + 0.25 mg/kg PQ

AL + 0.40 mg/kg PQ

P-values

P-values

% (n/N)

% (n/N)

% (n/N)

(AL vs.AL + 0.25 mg/kg PQ)

(AL vs.AL + 0.40 mg/kg PQ)

 Day 0

69.4 (34/49)

55.3 (26/47)

83.3 (40/48)

0.21

0.15

 Day 2

34.7 (17/49)

20.4 (9/44)

28.9 (13/45)

0.17

0.66

 Day 3

28.6 (14/49)

10.9 (5/46)

15.6 (7/45)

0.04

0.15

 Day 7

20.4 (10/49)

6.4 (3/47)

6.7 (3/45)

0.07

0.07

 Day 10

17.4 (8/46)

4.3 (2/47)

0.0 (0/44)

0.05

0.006

 Day 14

13.6 (6/44)

0.0 (0/40)

0.0 (0/38)

0.03

0.03

 Day 0

95.9 (47/49)

93.7 (45/48)

100.0 (46/46)

0.68

0.50

 Day 7

55.1 (27/49)

20.4 (10/49)

17.0 (8/47)

0.001

<0.001

Only patent gametocyte carriers at enrolment

AL

AL + 0.25 mg/kg PQ

AL + 0.40 mg/kg PQ

P-values

P-values

% (n/N)

% (n/N)

% (n/N)

(AL vs.AL + 0.25 mg/kg PQ)

(AL vs.AL + 0.40 mg/kg PQ)

 Day 0

95.6 (43/45)

98.0 (48/49)

98.0 (49/50)

0.60

0.60

 Day 2

93.2 (41/44)

87.5 (42/48)

90.4 (47/52)

0.49

0.72

 Day 3

88.4 (38/43)

75.5 (37/49)

92.2 (48/52)

0.18

0.72

 Day 7

66.7 (28/42)

34.0 (17/50)

27.8 (15/54)

0.003

<0.001

 Day 10

65.8 (27/41)

28.6 (14/49)

20.7 (11/53)

0.001

<0.001

 Day 14

42.5 (17/40)

10.2 (5/49)

16.7 (9/54)

0.001

0.01

Mean (95 % CI)

Mean (95 % CI)

Mean (95 % CI)

AUC gametocyte densities over time (in gametocytes μL^-1 days)^b

14.7 (5.5 – 24.0)

5.5 (1.1 – 10.0)

5.6 (2.1 – 9.1)

-

-

Gametocyte clearance time (in days)

19.7 (14.6 – 24.8)

7.7 (6.3 – 9.1)

8.2 (6.7 – 9.6)

-

-

P-values

P-values

AL vs. AL + 0.25 mg/kg PQ

AL vs. AL + 0.40 mg/kg PQ

AL + 0.25 mg/kg PQ vs. AL + 0.40 mg/kg PQ

(AL vs.AL + 0.25 mg/kg PQ)

(AL vs.AL + 0.40 mg/kg PQ)

Difference in gametocyte clearance time (in days)

12.0 (6.7 – 17.3)

11.5 (6.2 – 16.8)

-0.5 (- 2.5 – 1.6)

<0.001

<0.001