Background
Methods
Study participants
Enrolment, treatment and follow up
Laboratory investigations
Assessment of outcome
Statistical analysis
Results
Enrollment
SP N = 486 | AL N = 485 | |
---|---|---|
Mean weight (Kg) (SD) | 56.4 (10.1) | 56.3 (9.6) |
Number of women (%) | 245 (50.5) | 230 (47.4) |
Mean age (yr) (SD) | 27.0 (8.9) | 26.3 (8.3) |
Mean body temperature (°C) (SD) | 37.2 (1.2) | 37.3 (1.3) |
Mean white blood cell count (n*109/l) (SD)* | 5.1 (1.8) | 5.2 (1.8) |
Mean Hb (g/l) (SD) | 13.0 (2.2) | 13.2 (2.3) |
Mean (geometric) parasite density(/μl) (range)* | 8787 (406 – 103680) | 8405 (350–158894) |
Gametocytes prevalence (n)(%) | 16 (3.3) | 18 (3.7) |
N = 477
|
N = 481
| |
Weakness (%) | 344 (72.1) | 365 (75.9) |
Headache (%) | 428 (89.7) | 429 (89.2) |
Muscle/joint pain (%) | 316 (66.2) | 318 (66.2) |
Dizziness (%) | 176 (36.9) | 177 (36.7) |
Nausea (%) | 190 (39.9) | 180 (37.5) |
Vomiting (%) | 104 (21.7) | 113 (23.5) |
Diarrhoea (%) | 62 (13.1) | 59 (12.2) |
Abdominal pain (%) | 172 (36.1) | 163 (33.8) |
Heart palpitations (%) | 76 (16.0) | 76 (15.7) |
Backache (%) | 105 (22.0) | 119 (24.7) |
Jaundice** (%) | 51 (10.7) | 104 (21.7) |
Pallor** (%) | 6 (1.3) | 1 (0.3) |
Dark urine (%) | 51 (10.6) | 48 (9.9) |
Trial profile
Analysis of efficacy
Day 3 | Day 7 | Day 14 | Day 28 | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
SP
|
AL
|
P
|
SP
|
AL
|
P
|
SP
|
AL
|
P
|
SP
|
AL
|
P
| |
N
|
430
|
451
|
405
|
436
|
384
|
406
|
290
|
320
| ||||
Fever (%)
|
3.5
|
0.9
|
0.007
|
1.0
|
1.1
|
0.55
|
1.3
|
1.0
|
0.75
| 2.7 | 1.2 |
0.19
|
Parasitaemia
|
15.0
|
0.7
|
<0.001
|
2.0
|
0.0
|
NA
|
2,
|
0;5
|
0.009
|
5.5
|
1.2
|
0.003
|
Hemoglobin (mean)*(g/L)
|
-
|
-
|
-
|
-
|
124
|
129
|
0.003
|
130
|
134
|
0.02
| ||
Gametocyte carriage (N (%))
|
33 (7.6)
|
3 (0.7)
|
<0.001
|
88 (21.6)
|
2 (0.5)
|
<0.001
|
76 (19.8)
|
0 (0)
|
NA
|
10 (4.5)
|
1 (0,3)
|
0.004
|
Gametocyte densities (range)
|
48.6 (1–4320)
|
6.2 (1–240)
|
0.62
|
63.6 (1–4480)
|
8.9 (1–80)
|
0.51
|
52.8 (1–6960)
|
0(0)
|
NA
|
154.9 (3–840)
|
160
|
NA
|
N
|
430
|
448
|
400
|
428
|
382
|
401
|
303
|
329
| ||||
Weakness (%)
|
46.3
|
20.5
|
<0.001
|
15.0
|
6.1
|
<0.001
|
7.1
|
3.7
|
0.04
| 5.9 | 3.0 | 0.08 |
Headache (%)
|
45.6
|
22.5
|
<0.001
|
18.0
|
12.2
|
0.02
| 10.7 | 8.5 | 0.28 | 11.5 | 10.3 | 0.62 |
Muscle joint pain (%)
|
20.3
|
8.2
|
<0.001
|
5.2
|
2.6
|
0.004
| 3.8 | 2.8 | 0.47 | 2.3 | 2.8 | 0.73 |
Dizziness (%)
|
20.0
|
10.8
|
<0.001
| 5.2 | 3.0 | 0.11 | 2.1 | 1.0 | 0.21 | 2.7 | 1.2 | 0.18 |
Nausea (%)
|
15.8
|
2.9
|
<0.001
| 1.3 | 0.0 | NA | 0.8 | 0.5 | NA | 0.7 | 0.6 | NA |
Vomiting (%)
|
5.8
|
0.7
|
<0.001
| 0.5 | 0.2 | NA | 0.5 | 0.5 | NA | 0.0 | 0.3 | NA |
Diarrhoea (%)
|
3.8
|
7.7
|
0.013
| 0,9 | 2.5 | 0.08 | 1.3 | 2.7 | 0.16 | 0.7 | 1.2 | 0.78 |
Abdominal pain (%)
|
16.7
|
9.2
|
<0.001
| 7.0 | 4.0 | 0.06 | 3.4 | 3.5 | 0.94 | 5.0 | 3.7 | 0.41 |
Hear palpitations (%)
|
9.8
|
5.1
|
0.008
| 5.5 | 4.2 | 0.38 | 5.8 | 8.0 | 0.61 | 4.6 | 7.3 | 0.88 |
Back ache (%)
|
10.9
|
8.9
| 0.32 | 7.0 | 7.7 | 0.53 | 5.8 | 8.0 | 0.22 | 4.6 | 7.3 | 0.15 |
Treatment outcome n/N (%) | SP | AL | OR (95% CI) | P-value |
---|---|---|---|---|
ETF | 25/465 (6.4) | 2/462 (0.5) | 13.1 (3.08–55.50) | <0.001 |
LCF | 33/391 (8.4) | 14/404 (3.5) | 2.55 (1.34–4.84) | 0.004 |
LPF | 18/391 (4.6) | 6/404 (1.5) | 3.18 (1.25–8.09) | 0.02 |
TTF (PCR corrected) | 76/391 (19.3) | 22/404 (5.4) | 4.15 (2.52–6.83) | <0.001 |