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) | |
Gametocyte prevalence by microscopy | |||||
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) | - | - |
Gametocyte prevalence by Pfs25 QT-NASBA | |||||
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) | |
Gametocyte prevalence by microscopy | |||||
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 |
Gametocyte prevalence by Pfs25 QT-NASBA | |||||
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) | |
Gametocyte prevalence by Pfs25 qRT-PCR | |||||
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 |