Trial Outcomes & Findings for Albendazole Dose Finding and Pharmacokinetics in Children and Adults (NCT NCT03527745)
NCT ID: NCT03527745
Last Updated: 2023-06-12
Results Overview
The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
700 participants
Primary outcome timeframe
14-21 days after treatment
Results posted on
2023-06-12
Participant Flow
Participant milestones
| Measure |
Placebo Against T. Trichiura in PSAC
Placebo against T. trichiura in preschool-aged children
|
ALB 200 mg Against T. Trichiura in PSAC
200 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 400 mg Against T. Trichiura in PSAC
400 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 600 mg Against T. Trichiura in PSAC
600 mg of albendazole against T. trichiura in preschool-aged children
|
Placebo Against T. Trichiura in SAC
Placebo against T. trichiura in school-aged children
|
ALB 400 mg Against T. Trichiura in SAC
400 mg of albendazole against T. trichiura in school-aged children
|
ALB 600 mg Against T. Trichiura in SAC
600 mg of albendazole against T. trichiura in school-aged children
|
ALB 800 mg Against T. Trichiura in SAC
800 mg of albendazole against T. trichiura in school-aged children
|
Placebo Against T. Trichiura in Adults
Placebo against T. trichiura in adults
|
ALB 400 mg Against T. Trichiura in Adults
400 mg of albendazole against T. trichiura in adults
|
ALB 600 mg Against T. Trichiura in Adults
600 mg of albendazole against T. trichiura in adults
|
ALB 800 mg Against T. Trichiura in Adults
800 mg of albendazole against T. trichiura in adults
|
Placebo Against Hookworm in PSAC
Placebo against hookworm in preschool-aged children
|
ALB 200 mg Against Hookworm in PSAC
200 mg of albendazole against hookworm in preschool-aged children
|
ALB 400 mg Against Hookworm in PSAC
400 mg of albendazole against hookworm in preschool-aged children
|
ALB 600 mg Against Hookworm in PSAC
600 mg of albendazole against hookworm in preschool-aged children
|
Placebo Against Hookworm in SAC
Placebo against hookworm in school-aged children
|
ALB 200 mg Against Hookworm in SAC
200 mg of albendazole against hookworm in school-aged children
|
ALB 400 mg Against Hookworm in SAC
400 mg of albendazole against hookworm in school-aged children
|
ALB 600 mg Against Hookworm in SAC
600 mg of albendazole against hookworm in school-aged children
|
ALB 800 mg Against Hookworm in SAC
800 mg of albendazole against hookworm in school-aged children
|
Placebo Against Hookworm in Adults
Placebo against hookworm in adults
|
ALB 200 mg Against Hookworm in Adults
200 mg of albendazole against hookworm in adults
|
ALB 400 mg Against Hookworm in Adults
400 mg of albendazole against hookworm in adults
|
ALB 600 mg Against Hookworm in Adults
600 mg of albendazole against hookworm in adults
|
ALB 800 mg Against Hookworm in Adults
800 mg of albendazole against hookworm in adults
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
30
|
27
|
46
|
45
|
46
|
43
|
10
|
11
|
9
|
12
|
0
|
13
|
13
|
12
|
24
|
27
|
27
|
29
|
26
|
40
|
41
|
38
|
40
|
37
|
|
Overall Study
COMPLETED
|
24
|
21
|
23
|
18
|
46
|
43
|
43
|
41
|
7
|
9
|
8
|
11
|
0
|
13
|
13
|
12
|
23
|
27
|
27
|
28
|
25
|
35
|
35
|
30
|
39
|
34
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
7
|
9
|
0
|
2
|
3
|
2
|
3
|
2
|
1
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
5
|
6
|
8
|
1
|
3
|
Reasons for withdrawal
| Measure |
Placebo Against T. Trichiura in PSAC
Placebo against T. trichiura in preschool-aged children
|
ALB 200 mg Against T. Trichiura in PSAC
200 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 400 mg Against T. Trichiura in PSAC
400 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 600 mg Against T. Trichiura in PSAC
600 mg of albendazole against T. trichiura in preschool-aged children
|
Placebo Against T. Trichiura in SAC
Placebo against T. trichiura in school-aged children
|
ALB 400 mg Against T. Trichiura in SAC
400 mg of albendazole against T. trichiura in school-aged children
|
ALB 600 mg Against T. Trichiura in SAC
600 mg of albendazole against T. trichiura in school-aged children
|
ALB 800 mg Against T. Trichiura in SAC
800 mg of albendazole against T. trichiura in school-aged children
|
Placebo Against T. Trichiura in Adults
Placebo against T. trichiura in adults
|
ALB 400 mg Against T. Trichiura in Adults
400 mg of albendazole against T. trichiura in adults
|
ALB 600 mg Against T. Trichiura in Adults
600 mg of albendazole against T. trichiura in adults
|
ALB 800 mg Against T. Trichiura in Adults
800 mg of albendazole against T. trichiura in adults
|
Placebo Against Hookworm in PSAC
Placebo against hookworm in preschool-aged children
|
ALB 200 mg Against Hookworm in PSAC
200 mg of albendazole against hookworm in preschool-aged children
|
ALB 400 mg Against Hookworm in PSAC
400 mg of albendazole against hookworm in preschool-aged children
|
ALB 600 mg Against Hookworm in PSAC
600 mg of albendazole against hookworm in preschool-aged children
|
Placebo Against Hookworm in SAC
Placebo against hookworm in school-aged children
|
ALB 200 mg Against Hookworm in SAC
200 mg of albendazole against hookworm in school-aged children
|
ALB 400 mg Against Hookworm in SAC
400 mg of albendazole against hookworm in school-aged children
|
ALB 600 mg Against Hookworm in SAC
600 mg of albendazole against hookworm in school-aged children
|
ALB 800 mg Against Hookworm in SAC
800 mg of albendazole against hookworm in school-aged children
|
Placebo Against Hookworm in Adults
Placebo against hookworm in adults
|
ALB 200 mg Against Hookworm in Adults
200 mg of albendazole against hookworm in adults
|
ALB 400 mg Against Hookworm in Adults
400 mg of albendazole against hookworm in adults
|
ALB 600 mg Against Hookworm in Adults
600 mg of albendazole against hookworm in adults
|
ALB 800 mg Against Hookworm in Adults
800 mg of albendazole against hookworm in adults
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
7
|
9
|
0
|
2
|
3
|
2
|
3
|
2
|
1
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
5
|
6
|
8
|
1
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo Against T. Trichiura in PSAC
n=27 Participants
Placebo against T. trichiura in preschool-aged children
|
ALB 200 mg Against T. Trichiura in PSAC
n=27 Participants
200 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 400 mg Against T. Trichiura in PSAC
n=30 Participants
400 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 600 mg Against T. Trichiura in PSAC
n=27 Participants
600 mg of albendazole against T. trichiura in preschool-aged children
|
Placebo Against T. Trichiura in SAC
n=46 Participants
Placebo against T. trichiura in school-aged children
|
ALB 400 mg Against T. Trichiura in SAC
n=45 Participants
400 mg of albendazole against T. trichiura in school-aged children
|
ALB 600 mg Against T. Trichiura in SAC
n=46 Participants
600 mg of albendazole against T. trichiura in school-aged children
|
ALB 800 mg Against T. Trichiura in SAC
n=43 Participants
800 mg of albendazole against T. trichiura in school-aged children
|
Placebo Against T. Trichiura in Adults
n=10 Participants
Placebo against T. trichiura in adults (\>21 years)
|
ALB 400 mg Against T. Trichiura in Adults
n=11 Participants
400 mg of albendazole against T. trichiura in adults
|
ALB 600 mg Against T. Trichiura in Adults
n=9 Participants
600 mg of albendazole against T. trichiura in adults
|
ALB 800 mg Against T. Trichiura in Adults
n=12 Participants
800 mg of albendazole against T. trichiura in adults
|
Placebo Against Hookworm in PSAC
Placebo against hookworm in preschool-aged children
|
ALB 200 mg Against Hookworm in PSAC
n=13 Participants
200 mg of albendazole against hookworm in preschool-aged children
|
ALB 400 mg Against Hookworm in PSAC
n=13 Participants
400 mg of albendazole against hookworm in preschool-aged children
|
ALB 600 mg Against Hookworm in PSAC
n=12 Participants
600 mg of albendazole against hookworm in preschool-aged children
|
Placebo Against Hookworm in SAC
n=24 Participants
Placebo against hookworm in school-aged children
|
ALB 200 mg Against Hookworm in SAC
n=27 Participants
200 mg of albendazole against hookworm in school-aged children
|
ALB 400 mg Against Hookworm in SAC
n=27 Participants
400 mg of albendazole against hookworm in school-aged children
|
ALB 600 mg Against Hookworm in SAC
n=29 Participants
600 mg of albendazole against hookworm in school-aged children
|
ALB 800 mg Against Hookworm in SAC
n=26 Participants
800 mg of albendazole against hookworm in school-aged children
|
Placebo Against Hookworm in Adults
n=40 Participants
Placebo against hookworm in adults (\>21 years)
|
ALB 200 mg Against Hookworm in Adults
n=41 Participants
200 mg of albendazole against hookworm in adults
|
ALB 400 mg Against Hookworm in Adults
n=38 Participants
400 mg of albendazole against hookworm in adults
|
ALB 600 mg Against Hookworm in Adults
n=40 Participants
600 mg of albendazole against hookworm in adults
|
ALB 800 mg Against Hookworm in Adults
n=37 Participants
800 mg of albendazole against hookworm in adults
|
Total
n=700 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
T. trichuris median eggs per gram
|
216 eggs per gram of stool
n=27 Participants
|
264 eggs per gram of stool
n=27 Participants
|
210 eggs per gram of stool
n=30 Participants
|
228 eggs per gram of stool
n=27 Participants
|
387 eggs per gram of stool
n=46 Participants
|
426 eggs per gram of stool
n=45 Participants
|
507 eggs per gram of stool
n=46 Participants
|
414 eggs per gram of stool
n=43 Participants
|
138 eggs per gram of stool
n=10 Participants
|
168 eggs per gram of stool
n=11 Participants
|
156 eggs per gram of stool
n=9 Participants
|
195 eggs per gram of stool
n=12 Participants
|
—
|
0 eggs per gram of stool
n=13 Participants
|
0 eggs per gram of stool
n=13 Participants
|
0 eggs per gram of stool
n=12 Participants
|
0 eggs per gram of stool
n=24 Participants
|
0 eggs per gram of stool
n=27 Participants
|
0 eggs per gram of stool
n=27 Participants
|
0 eggs per gram of stool
n=29 Participants
|
0 eggs per gram of stool
n=26 Participants
|
0 eggs per gram of stool
n=40 Participants
|
0 eggs per gram of stool
n=41 Participants
|
0 eggs per gram of stool
n=38 Participants
|
0 eggs per gram of stool
n=40 Participants
|
0 eggs per gram of stool
n=37 Participants
|
294 eggs per gram of stool
n=700 Participants
|
|
Age, Continuous
Age
|
4.1 years
STANDARD_DEVIATION 0.9 • n=27 Participants
|
4.0 years
STANDARD_DEVIATION 0.9 • n=27 Participants
|
3.8 years
STANDARD_DEVIATION 1.1 • n=30 Participants
|
4.0 years
STANDARD_DEVIATION 0.9 • n=27 Participants
|
8.9 years
STANDARD_DEVIATION 1.9 • n=46 Participants
|
8.9 years
STANDARD_DEVIATION 1.9 • n=45 Participants
|
8.7 years
STANDARD_DEVIATION 2.0 • n=46 Participants
|
8.8 years
STANDARD_DEVIATION 1.8 • n=43 Participants
|
44.3 years
STANDARD_DEVIATION 12.3 • n=10 Participants
|
40.5 years
STANDARD_DEVIATION 11.9 • n=11 Participants
|
36.6 years
STANDARD_DEVIATION 12.2 • n=9 Participants
|
44.8 years
STANDARD_DEVIATION 15.9 • n=12 Participants
|
—
|
3.8 years
STANDARD_DEVIATION 1.2 • n=13 Participants
|
3.8 years
STANDARD_DEVIATION 1.3 • n=13 Participants
|
3.8 years
STANDARD_DEVIATION 1.1 • n=12 Participants
|
9.1 years
STANDARD_DEVIATION 2.2 • n=24 Participants
|
9.1 years
STANDARD_DEVIATION 1.9 • n=27 Participants
|
9.8 years
STANDARD_DEVIATION 1.9 • n=27 Participants
|
9.2 years
STANDARD_DEVIATION 2.2 • n=29 Participants
|
9.4 years
STANDARD_DEVIATION 2.3 • n=26 Participants
|
35.4 years
STANDARD_DEVIATION 10.3 • n=40 Participants
|
39.8 years
STANDARD_DEVIATION 12.2 • n=41 Participants
|
36.3 years
STANDARD_DEVIATION 12.2 • n=38 Participants
|
39.2 years
STANDARD_DEVIATION 11.5 • n=40 Participants
|
35.7 years
STANDARD_DEVIATION 12.0 • n=37 Participants
|
17.7 years
STANDARD_DEVIATION 16.3 • n=700 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=27 Participants
|
18 Participants
n=27 Participants
|
16 Participants
n=30 Participants
|
18 Participants
n=27 Participants
|
25 Participants
n=46 Participants
|
15 Participants
n=45 Participants
|
19 Participants
n=46 Participants
|
17 Participants
n=43 Participants
|
6 Participants
n=10 Participants
|
9 Participants
n=11 Participants
|
7 Participants
n=9 Participants
|
8 Participants
n=12 Participants
|
—
|
5 Participants
n=13 Participants
|
9 Participants
n=13 Participants
|
8 Participants
n=12 Participants
|
8 Participants
n=24 Participants
|
12 Participants
n=27 Participants
|
8 Participants
n=27 Participants
|
5 Participants
n=29 Participants
|
7 Participants
n=26 Participants
|
7 Participants
n=40 Participants
|
16 Participants
n=41 Participants
|
7 Participants
n=38 Participants
|
7 Participants
n=40 Participants
|
9 Participants
n=37 Participants
|
282 Participants
n=700 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=27 Participants
|
9 Participants
n=27 Participants
|
14 Participants
n=30 Participants
|
9 Participants
n=27 Participants
|
21 Participants
n=46 Participants
|
30 Participants
n=45 Participants
|
27 Participants
n=46 Participants
|
26 Participants
n=43 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=11 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=12 Participants
|
—
|
8 Participants
n=13 Participants
|
4 Participants
n=13 Participants
|
4 Participants
n=12 Participants
|
16 Participants
n=24 Participants
|
15 Participants
n=27 Participants
|
19 Participants
n=27 Participants
|
24 Participants
n=29 Participants
|
19 Participants
n=26 Participants
|
33 Participants
n=40 Participants
|
25 Participants
n=41 Participants
|
31 Participants
n=38 Participants
|
33 Participants
n=40 Participants
|
28 Participants
n=37 Participants
|
418 Participants
n=700 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
T. trichuris infection intensity
Light (1-999 epg)
|
22 Participants
n=27 Participants
|
22 Participants
n=27 Participants
|
24 Participants
n=30 Participants
|
21 Participants
n=27 Participants
|
32 Participants
n=46 Participants
|
30 Participants
n=45 Participants
|
31 Participants
n=46 Participants
|
30 Participants
n=43 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
10 Participants
n=12 Participants
|
—
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
2 Participants
n=26 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=37 Participants
|
260 Participants
n=700 Participants
|
|
T. trichuris infection intensity
Moderate (1000-9999 epg)
|
4 Participants
n=27 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=30 Participants
|
6 Participants
n=27 Participants
|
14 Participants
n=46 Participants
|
15 Participants
n=45 Participants
|
15 Participants
n=46 Participants
|
12 Participants
n=43 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=12 Participants
|
—
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=37 Participants
|
79 Participants
n=700 Participants
|
|
T. trichuris infection intensity
Heavy (>= 10000 epg)
|
1 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=46 Participants
|
1 Participants
n=43 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=12 Participants
|
—
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=37 Participants
|
3 Participants
n=700 Participants
|
|
T. trichuris infection intensity
Not infected
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=12 Participants
|
—
|
13 Participants
n=13 Participants
|
13 Participants
n=13 Participants
|
11 Participants
n=12 Participants
|
22 Participants
n=24 Participants
|
25 Participants
n=27 Participants
|
27 Participants
n=27 Participants
|
29 Participants
n=29 Participants
|
24 Participants
n=26 Participants
|
39 Participants
n=40 Participants
|
41 Participants
n=41 Participants
|
38 Participants
n=38 Participants
|
40 Participants
n=40 Participants
|
36 Participants
n=37 Participants
|
358 Participants
n=700 Participants
|
|
hookworm median eggs per gram
|
0 eggs per gram of stool
n=27 Participants
|
0 eggs per gram of stool
n=27 Participants
|
0 eggs per gram of stool
n=30 Participants
|
0 eggs per gram of stool
n=27 Participants
|
0 eggs per gram of stool
n=46 Participants
|
0 eggs per gram of stool
n=45 Participants
|
0 eggs per gram of stool
n=46 Participants
|
0 eggs per gram of stool
n=43 Participants
|
0 eggs per gram of stool
n=10 Participants
|
0 eggs per gram of stool
n=11 Participants
|
0 eggs per gram of stool
n=9 Participants
|
0 eggs per gram of stool
n=12 Participants
|
—
|
216 eggs per gram of stool
n=13 Participants
|
126 eggs per gram of stool
n=13 Participants
|
252 eggs per gram of stool
n=12 Participants
|
183 eggs per gram of stool
n=24 Participants
|
126 eggs per gram of stool
n=27 Participants
|
138 eggs per gram of stool
n=27 Participants
|
156 eggs per gram of stool
n=29 Participants
|
153 eggs per gram of stool
n=26 Participants
|
157 eggs per gram of stool
n=40 Participants
|
126 eggs per gram of stool
n=41 Participants
|
96 eggs per gram of stool
n=38 Participants
|
189 eggs per gram of stool
n=40 Participants
|
114 eggs per gram of stool
n=37 Participants
|
132 eggs per gram of stool
n=700 Participants
|
|
hookworm infection intensity
Light (1-1999 epg)
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=46 Participants
|
1 Participants
n=45 Participants
|
2 Participants
n=46 Participants
|
3 Participants
n=43 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=12 Participants
|
—
|
12 Participants
n=13 Participants
|
12 Participants
n=13 Participants
|
11 Participants
n=12 Participants
|
22 Participants
n=24 Participants
|
26 Participants
n=27 Participants
|
27 Participants
n=27 Participants
|
27 Participants
n=29 Participants
|
24 Participants
n=26 Participants
|
38 Participants
n=40 Participants
|
40 Participants
n=41 Participants
|
38 Participants
n=38 Participants
|
40 Participants
n=40 Participants
|
36 Participants
n=37 Participants
|
363 Participants
n=700 Participants
|
|
hookworm infection intensity
Moderate (2000-3999 epg)
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=12 Participants
|
—
|
1 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=29 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=37 Participants
|
12 Participants
n=700 Participants
|
|
hookworm infection intensity
Heavy (>= 4000 epg)
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=12 Participants
|
—
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=37 Participants
|
2 Participants
n=700 Participants
|
|
hookworm infection intensity
Not infected
|
27 Participants
n=27 Participants
|
27 Participants
n=27 Participants
|
29 Participants
n=30 Participants
|
27 Participants
n=27 Participants
|
45 Participants
n=46 Participants
|
44 Participants
n=45 Participants
|
44 Participants
n=46 Participants
|
40 Participants
n=43 Participants
|
9 Participants
n=10 Participants
|
10 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
12 Participants
n=12 Participants
|
—
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=37 Participants
|
323 Participants
n=700 Participants
|
|
A. lumbricoides infection intensity
Light (1-4999 epg)
|
2 Participants
n=27 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=27 Participants
|
8 Participants
n=46 Participants
|
8 Participants
n=45 Participants
|
4 Participants
n=46 Participants
|
6 Participants
n=43 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=12 Participants
|
—
|
1 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=29 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=37 Participants
|
44 Participants
n=700 Participants
|
|
A. lumbricoides infection intensity
Moderate (5000-49999 epg)
|
2 Participants
n=27 Participants
|
6 Participants
n=27 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=46 Participants
|
9 Participants
n=45 Participants
|
6 Participants
n=46 Participants
|
7 Participants
n=43 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=12 Participants
|
—
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=37 Participants
|
41 Participants
n=700 Participants
|
|
A. lumbricoides infection intensity
Heavy (>= 50000 epg)
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=46 Participants
|
1 Participants
n=45 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=12 Participants
|
—
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=700 Participants
|
|
A. lumbricoides infection intensity
Not infected
|
23 Participants
n=27 Participants
|
19 Participants
n=27 Participants
|
25 Participants
n=30 Participants
|
24 Participants
n=27 Participants
|
33 Participants
n=46 Participants
|
27 Participants
n=45 Participants
|
36 Participants
n=46 Participants
|
30 Participants
n=43 Participants
|
10 Participants
n=10 Participants
|
8 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
9 Participants
n=12 Participants
|
—
|
12 Participants
n=13 Participants
|
13 Participants
n=13 Participants
|
11 Participants
n=12 Participants
|
23 Participants
n=24 Participants
|
26 Participants
n=27 Participants
|
27 Participants
n=27 Participants
|
28 Participants
n=29 Participants
|
26 Participants
n=26 Participants
|
40 Participants
n=40 Participants
|
41 Participants
n=41 Participants
|
38 Participants
n=38 Participants
|
39 Participants
n=40 Participants
|
37 Participants
n=37 Participants
|
614 Participants
n=700 Participants
|
PRIMARY outcome
Timeframe: 14-21 days after treatmentPopulation: An analysis set of all randomized participants who provided any follow-up data was used to perform an available-case analysis.
The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).
Outcome measures
| Measure |
Placebo Against T. Trichiura in PSAC
n=24 Participants
Placebo against T. trichiura in preschool-aged children
|
ALB 200 mg Against T. Trichiura in PSAC
n=21 Participants
200 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 400 mg Against T. Trichiura in PSAC
n=23 Participants
400 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 600 mg Against T. Trichiura in PSAC
n=18 Participants
600 mg of albendazole against T. trichiura in preschool-aged children
|
Placebo Against T. Trichiura in SAC
n=46 Participants
Placebo against T. trichiura in school-aged children
|
ALB 400 mg Against T. Trichiura in SAC
n=43 Participants
400 mg of albendazole against T. trichiura in school-aged children
|
ALB 600 mg Against T. Trichiura in SAC
n=43 Participants
600 mg of albendazole against T. trichiura in school-aged children
|
ALB 800 mg Against T. Trichiura in SAC
n=41 Participants
800 mg of albendazole against T. trichiura in school-aged children
|
Placebo Against T. Trichiura in Adults
n=7 Participants
Placebo against T. trichiura in adults
|
ALB 400 mg Against T. Trichiura in Adults
n=9 Participants
400 mg of albendazole against T. trichiura in adults
|
ALB 600 mg Against T. Trichiura in Adults
n=8 Participants
600 mg of albendazole against T. trichiura in adults
|
ALB 800 mg Against T. Trichiura in Adults
n=11 Participants
800 mg of albendazole against T. trichiura in adults
|
Placebo Against Hookworm in PSAC
Placebo against hookworm in preschool-aged children
|
ALB 200 mg Against Hookworm in PSAC
n=13 Participants
200 mg of albendazole against hookworm in preschool-aged children
|
ALB 400 mg Against Hookworm in PSAC
n=13 Participants
400 mg of albendazole against hookworm in preschool-aged children
|
ALB 600 mg Against Hookworm in PSAC
n=12 Participants
600 mg of albendazole against hookworm in preschool-aged children
|
Placebo Against Hookworm in SAC
n=23 Participants
Placebo against hookworm in school-aged children
|
ALB 200 mg Against Hookworm in SAC
n=27 Participants
200 mg of albendazole against hookworm in school-aged children
|
ALB 400 mg Against Hookworm in SAC
n=27 Participants
400 mg of albendazole against hookworm in school-aged children
|
ALB 600 mg Against Hookworm in SAC
n=28 Participants
600 mg of albendazole against hookworm in school-aged children
|
ALB 800 mg Against Hookworm in SAC
n=25 Participants
800 mg of albendazole against hookworm in school-aged children
|
Placebo Against Hookworm in Adults
n=35 Participants
Placebo against hookworm in adults
|
ALB 200 mg Against Hookworm in Adults
n=35 Participants
200 mg of albendazole against hookworm in adults
|
ALB 400 mg Against Hookworm in Adults
n=30 Participants
400 mg of albendazole against hookworm in adults
|
ALB 600 mg Against Hookworm in Adults
n=39 Participants
600 mg of albendazole against hookworm in adults
|
ALB 800 mg Against Hookworm in Adults
n=34 Participants
800 mg of albendazole against hookworm in adults
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cure Rate Against T. Trichiura and Hookworm Infections
Cured
|
4 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
7 Participants
|
11 Participants
|
7 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
—
|
9 Participants
|
8 Participants
|
10 Participants
|
10 Participants
|
17 Participants
|
20 Participants
|
18 Participants
|
19 Participants
|
5 Participants
|
16 Participants
|
16 Participants
|
22 Participants
|
32 Participants
|
|
Cure Rate Against T. Trichiura and Hookworm Infections
Not cured
|
20 Participants
|
19 Participants
|
19 Participants
|
13 Participants
|
43 Participants
|
36 Participants
|
32 Participants
|
34 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
—
|
4 Participants
|
5 Participants
|
2 Participants
|
13 Participants
|
10 Participants
|
7 Participants
|
10 Participants
|
6 Participants
|
30 Participants
|
19 Participants
|
14 Participants
|
17 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 14-21 days after treatmentPopulation: An analysis set of all randomized participants who provided any follow-up data was used to perform an available-case analysis.
Percent change in geometric mean eggs per gram of stool from before to after treatment
Outcome measures
| Measure |
Placebo Against T. Trichiura in PSAC
n=24 Participants
Placebo against T. trichiura in preschool-aged children
|
ALB 200 mg Against T. Trichiura in PSAC
n=21 Participants
200 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 400 mg Against T. Trichiura in PSAC
n=23 Participants
400 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 600 mg Against T. Trichiura in PSAC
n=18 Participants
600 mg of albendazole against T. trichiura in preschool-aged children
|
Placebo Against T. Trichiura in SAC
n=46 Participants
Placebo against T. trichiura in school-aged children
|
ALB 400 mg Against T. Trichiura in SAC
n=43 Participants
400 mg of albendazole against T. trichiura in school-aged children
|
ALB 600 mg Against T. Trichiura in SAC
n=43 Participants
600 mg of albendazole against T. trichiura in school-aged children
|
ALB 800 mg Against T. Trichiura in SAC
n=41 Participants
800 mg of albendazole against T. trichiura in school-aged children
|
Placebo Against T. Trichiura in Adults
n=7 Participants
Placebo against T. trichiura in adults
|
ALB 400 mg Against T. Trichiura in Adults
n=9 Participants
400 mg of albendazole against T. trichiura in adults
|
ALB 600 mg Against T. Trichiura in Adults
n=8 Participants
600 mg of albendazole against T. trichiura in adults
|
ALB 800 mg Against T. Trichiura in Adults
n=11 Participants
800 mg of albendazole against T. trichiura in adults
|
Placebo Against Hookworm in PSAC
Placebo against hookworm in preschool-aged children
|
ALB 200 mg Against Hookworm in PSAC
n=13 Participants
200 mg of albendazole against hookworm in preschool-aged children
|
ALB 400 mg Against Hookworm in PSAC
n=13 Participants
400 mg of albendazole against hookworm in preschool-aged children
|
ALB 600 mg Against Hookworm in PSAC
n=12 Participants
600 mg of albendazole against hookworm in preschool-aged children
|
Placebo Against Hookworm in SAC
n=23 Participants
Placebo against hookworm in school-aged children
|
ALB 200 mg Against Hookworm in SAC
n=27 Participants
200 mg of albendazole against hookworm in school-aged children
|
ALB 400 mg Against Hookworm in SAC
n=27 Participants
400 mg of albendazole against hookworm in school-aged children
|
ALB 600 mg Against Hookworm in SAC
n=28 Participants
600 mg of albendazole against hookworm in school-aged children
|
ALB 800 mg Against Hookworm in SAC
n=25 Participants
800 mg of albendazole against hookworm in school-aged children
|
Placebo Against Hookworm in Adults
n=35 Participants
Placebo against hookworm in adults
|
ALB 200 mg Against Hookworm in Adults
n=35 Participants
200 mg of albendazole against hookworm in adults
|
ALB 400 mg Against Hookworm in Adults
n=30 Participants
400 mg of albendazole against hookworm in adults
|
ALB 600 mg Against Hookworm in Adults
n=39 Participants
600 mg of albendazole against hookworm in adults
|
ALB 800 mg Against Hookworm in Adults
n=34 Participants
800 mg of albendazole against hookworm in adults
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Egg-reduction Rate (ERR) Against T. Trichiura and Hookworm Infections, Respectively
|
79.1 percent change
Interval 53.5 to 91.2
|
63.8 percent change
Interval 33.1 to 83.1
|
87.1 percent change
Interval 67.3 to 95.3
|
88.5 percent change
Interval 70.4 to 95.7
|
55.9 percent change
Interval 26.1 to 75.2
|
82.0 percent change
Interval 67.8 to 90.5
|
88.4 percent change
Interval 74.8 to 94.8
|
78.7 percent change
Interval 60.5 to 89.1
|
85.2 percent change
Interval 65.9 to 95.3
|
97.7 percent change
Interval 86.7 to 99.8
|
94.7 percent change
Interval 61.0 to 99.6
|
92.6 percent change
Interval 71.9 to 98.5
|
—
|
99.0 percent change
Interval 94.7 to 99.9
|
96.2 percent change
Interval 83.5 to 99.4
|
99.6 percent change
Interval 98.5 to 100.0
|
90.6 percent change
Interval 72.3 to 97.3
|
97.7 percent change
Interval 93.5 to 99.3
|
99.0 percent change
Interval 97.4 to 99.7
|
98.3 percent change
Interval 95.4 to 99.5
|
98.4 percent change
Interval 95.9 to 99.6
|
33.0 percent change
Interval -27.1 to 67.3
|
93.8 percent change
Interval 87.0 to 97.3
|
95.8 percent change
Interval 90.2 to 98.3
|
97.0 percent change
Interval 92.5 to 98.9
|
99.8 percent change
Interval 99.5 to 100.0
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosingTo determine maximum drug concentration (Cmax) of albendazole and its metabolites in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole sulfoxide will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml.
Outcome measures
| Measure |
Placebo Against T. Trichiura in PSAC
n=10 Participants
Placebo against T. trichiura in preschool-aged children
|
ALB 200 mg Against T. Trichiura in PSAC
n=16 Participants
200 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 400 mg Against T. Trichiura in PSAC
n=16 Participants
400 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 600 mg Against T. Trichiura in PSAC
n=14 Participants
600 mg of albendazole against T. trichiura in preschool-aged children
|
Placebo Against T. Trichiura in SAC
n=15 Participants
Placebo against T. trichiura in school-aged children
|
ALB 400 mg Against T. Trichiura in SAC
n=14 Participants
400 mg of albendazole against T. trichiura in school-aged children
|
ALB 600 mg Against T. Trichiura in SAC
n=11 Participants
600 mg of albendazole against T. trichiura in school-aged children
|
ALB 800 mg Against T. Trichiura in SAC
n=8 Participants
800 mg of albendazole against T. trichiura in school-aged children
|
Placebo Against T. Trichiura in Adults
n=10 Participants
Placebo against T. trichiura in adults
|
ALB 400 mg Against T. Trichiura in Adults
n=13 Participants
400 mg of albendazole against T. trichiura in adults
|
ALB 600 mg Against T. Trichiura in Adults
n=7 Participants
600 mg of albendazole against T. trichiura in adults
|
ALB 800 mg Against T. Trichiura in Adults
n=10 Participants
800 mg of albendazole against T. trichiura in adults
|
Placebo Against Hookworm in PSAC
n=18 Participants
Placebo against hookworm in preschool-aged children
|
ALB 200 mg Against Hookworm in PSAC
n=14 Participants
200 mg of albendazole against hookworm in preschool-aged children
|
ALB 400 mg Against Hookworm in PSAC
n=14 Participants
400 mg of albendazole against hookworm in preschool-aged children
|
ALB 600 mg Against Hookworm in PSAC
n=16 Participants
600 mg of albendazole against hookworm in preschool-aged children
|
Placebo Against Hookworm in SAC
n=11 Participants
Placebo against hookworm in school-aged children
|
ALB 200 mg Against Hookworm in SAC
n=12 Participants
200 mg of albendazole against hookworm in school-aged children
|
ALB 400 mg Against Hookworm in SAC
n=12 Participants
400 mg of albendazole against hookworm in school-aged children
|
ALB 600 mg Against Hookworm in SAC
n=12 Participants
600 mg of albendazole against hookworm in school-aged children
|
ALB 800 mg Against Hookworm in SAC
800 mg of albendazole against hookworm in school-aged children
|
Placebo Against Hookworm in Adults
Placebo against hookworm in adults
|
ALB 200 mg Against Hookworm in Adults
200 mg of albendazole against hookworm in adults
|
ALB 400 mg Against Hookworm in Adults
400 mg of albendazole against hookworm in adults
|
ALB 600 mg Against Hookworm in Adults
600 mg of albendazole against hookworm in adults
|
ALB 800 mg Against Hookworm in Adults
800 mg of albendazole against hookworm in adults
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of Albendazole Sulphoxide
|
3.41 mikromol/L
Standard Deviation 2.58
|
6.61 mikromol/L
Standard Deviation 4.56
|
9.98 mikromol/L
Standard Deviation 7.16
|
3.67 mikromol/L
Standard Deviation 2.54
|
5.51 mikromol/L
Standard Deviation 3.778
|
7.14 mikromol/L
Standard Deviation 4.82
|
2.03 mikromol/L
Standard Deviation 1.44
|
2.95 mikromol/L
Standard Deviation 1.89
|
4.03 mikromol/L
Standard Deviation 2.62
|
1.70 mikromol/L
Standard Deviation 1.28
|
3.27 mikromol/L
Standard Deviation 2.28
|
4.98 mikromol/L
Standard Deviation 3.61
|
1.02 mikromol/L
Standard Deviation 0.74
|
2.11 mikromol/L
Standard Deviation 1.56
|
3.16 mikromol/L
Standard Deviation 2.41
|
4.12 mikromol/L
Standard Deviation 3.21
|
0.61 mikromol/L
Standard Deviation 0.44
|
1.22 mikromol/L
Standard Deviation 0.91
|
1.78 mikromol/L
Standard Deviation 1.20
|
2.43 mikromol/L
Standard Deviation 1.71
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosingTo determine time to reach Cmax (tmax) of albendazole and its metabolites in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole sulfoxide was quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml.
Outcome measures
| Measure |
Placebo Against T. Trichiura in PSAC
n=10 Participants
Placebo against T. trichiura in preschool-aged children
|
ALB 200 mg Against T. Trichiura in PSAC
n=16 Participants
200 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 400 mg Against T. Trichiura in PSAC
n=16 Participants
400 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 600 mg Against T. Trichiura in PSAC
n=14 Participants
600 mg of albendazole against T. trichiura in preschool-aged children
|
Placebo Against T. Trichiura in SAC
n=15 Participants
Placebo against T. trichiura in school-aged children
|
ALB 400 mg Against T. Trichiura in SAC
n=14 Participants
400 mg of albendazole against T. trichiura in school-aged children
|
ALB 600 mg Against T. Trichiura in SAC
n=11 Participants
600 mg of albendazole against T. trichiura in school-aged children
|
ALB 800 mg Against T. Trichiura in SAC
n=8 Participants
800 mg of albendazole against T. trichiura in school-aged children
|
Placebo Against T. Trichiura in Adults
n=10 Participants
Placebo against T. trichiura in adults
|
ALB 400 mg Against T. Trichiura in Adults
n=13 Participants
400 mg of albendazole against T. trichiura in adults
|
ALB 600 mg Against T. Trichiura in Adults
n=7 Participants
600 mg of albendazole against T. trichiura in adults
|
ALB 800 mg Against T. Trichiura in Adults
n=10 Participants
800 mg of albendazole against T. trichiura in adults
|
Placebo Against Hookworm in PSAC
n=18 Participants
Placebo against hookworm in preschool-aged children
|
ALB 200 mg Against Hookworm in PSAC
n=14 Participants
200 mg of albendazole against hookworm in preschool-aged children
|
ALB 400 mg Against Hookworm in PSAC
n=14 Participants
400 mg of albendazole against hookworm in preschool-aged children
|
ALB 600 mg Against Hookworm in PSAC
n=16 Participants
600 mg of albendazole against hookworm in preschool-aged children
|
Placebo Against Hookworm in SAC
n=11 Participants
Placebo against hookworm in school-aged children
|
ALB 200 mg Against Hookworm in SAC
n=12 Participants
200 mg of albendazole against hookworm in school-aged children
|
ALB 400 mg Against Hookworm in SAC
n=12 Participants
400 mg of albendazole against hookworm in school-aged children
|
ALB 600 mg Against Hookworm in SAC
n=12 Participants
600 mg of albendazole against hookworm in school-aged children
|
ALB 800 mg Against Hookworm in SAC
800 mg of albendazole against hookworm in school-aged children
|
Placebo Against Hookworm in Adults
Placebo against hookworm in adults
|
ALB 200 mg Against Hookworm in Adults
200 mg of albendazole against hookworm in adults
|
ALB 400 mg Against Hookworm in Adults
400 mg of albendazole against hookworm in adults
|
ALB 600 mg Against Hookworm in Adults
600 mg of albendazole against hookworm in adults
|
ALB 800 mg Against Hookworm in Adults
800 mg of albendazole against hookworm in adults
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Cmax (Tmax) of Albendazole Sulphoxide
|
6.8 hours
Standard Deviation 4.4
|
6.8 hours
Standard Deviation 3.8
|
6.8 hours
Standard Deviation 4.1
|
7.1 hours
Standard Deviation 4.6
|
7.0 hours
Standard Deviation 4.4
|
7.1 hours
Standard Deviation 4.3
|
7.3 hours
Standard Deviation 4.3
|
7.2 hours
Standard Deviation 4.3
|
7.4 hours
Standard Deviation 4.5
|
4.2 hours
Standard Deviation 2.7
|
4.2 hours
Standard Deviation 2.4
|
4.2 hours
Standard Deviation 2.6
|
4.5 hours
Standard Deviation 2.8
|
4.7 hours
Standard Deviation 3.1
|
4.7 hours
Standard Deviation 3.0
|
4.8 hours
Standard Deviation 3.0
|
5.3 hours
Standard Deviation 3.2
|
5.3 hours
Standard Deviation 3.2
|
5.4 hours
Standard Deviation 3.3
|
5.4 hours
Standard Deviation 3.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosingTo determine the area under the curve (AUC) of albendazole sulphoxide in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole and its metabolites (albendazole sulfoxide and albendazole sulfone) will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml.
Outcome measures
| Measure |
Placebo Against T. Trichiura in PSAC
n=10 Participants
Placebo against T. trichiura in preschool-aged children
|
ALB 200 mg Against T. Trichiura in PSAC
n=16 Participants
200 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 400 mg Against T. Trichiura in PSAC
n=16 Participants
400 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 600 mg Against T. Trichiura in PSAC
n=14 Participants
600 mg of albendazole against T. trichiura in preschool-aged children
|
Placebo Against T. Trichiura in SAC
n=15 Participants
Placebo against T. trichiura in school-aged children
|
ALB 400 mg Against T. Trichiura in SAC
n=14 Participants
400 mg of albendazole against T. trichiura in school-aged children
|
ALB 600 mg Against T. Trichiura in SAC
n=11 Participants
600 mg of albendazole against T. trichiura in school-aged children
|
ALB 800 mg Against T. Trichiura in SAC
n=8 Participants
800 mg of albendazole against T. trichiura in school-aged children
|
Placebo Against T. Trichiura in Adults
n=10 Participants
Placebo against T. trichiura in adults
|
ALB 400 mg Against T. Trichiura in Adults
n=13 Participants
400 mg of albendazole against T. trichiura in adults
|
ALB 600 mg Against T. Trichiura in Adults
n=7 Participants
600 mg of albendazole against T. trichiura in adults
|
ALB 800 mg Against T. Trichiura in Adults
n=10 Participants
800 mg of albendazole against T. trichiura in adults
|
Placebo Against Hookworm in PSAC
n=18 Participants
Placebo against hookworm in preschool-aged children
|
ALB 200 mg Against Hookworm in PSAC
n=14 Participants
200 mg of albendazole against hookworm in preschool-aged children
|
ALB 400 mg Against Hookworm in PSAC
n=14 Participants
400 mg of albendazole against hookworm in preschool-aged children
|
ALB 600 mg Against Hookworm in PSAC
n=16 Participants
600 mg of albendazole against hookworm in preschool-aged children
|
Placebo Against Hookworm in SAC
n=11 Participants
Placebo against hookworm in school-aged children
|
ALB 200 mg Against Hookworm in SAC
n=12 Participants
200 mg of albendazole against hookworm in school-aged children
|
ALB 400 mg Against Hookworm in SAC
n=12 Participants
400 mg of albendazole against hookworm in school-aged children
|
ALB 600 mg Against Hookworm in SAC
n=12 Participants
600 mg of albendazole against hookworm in school-aged children
|
ALB 800 mg Against Hookworm in SAC
800 mg of albendazole against hookworm in school-aged children
|
Placebo Against Hookworm in Adults
Placebo against hookworm in adults
|
ALB 200 mg Against Hookworm in Adults
200 mg of albendazole against hookworm in adults
|
ALB 400 mg Against Hookworm in Adults
400 mg of albendazole against hookworm in adults
|
ALB 600 mg Against Hookworm in Adults
600 mg of albendazole against hookworm in adults
|
ALB 800 mg Against Hookworm in Adults
800 mg of albendazole against hookworm in adults
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve (AUC) of Albendazole Sulphoxide
|
45.3 micogram/ml/h-1
Standard Deviation 31.4
|
90.3 micogram/ml/h-1
Standard Deviation 58.7
|
135.4 micogram/ml/h-1
Standard Deviation 89.6
|
47.3 micogram/ml/h-1
Standard Deviation 27.7
|
73.1 micogram/ml/h-1
Standard Deviation 44.2
|
96.9 micogram/ml/h-1
Standard Deviation 58.3
|
26.99 micogram/ml/h-1
Standard Deviation 15.9
|
40.2 micogram/ml/h-1
Standard Deviation 23.4
|
53.4 micogram/ml/h-1
Standard Deviation 29.9
|
16.6 micogram/ml/h-1
Standard Deviation 10.1
|
33.1 micogram/ml/h-1
Standard Deviation 18.8
|
49.5 micogram/ml/h-1
Standard Deviation 28.5
|
11.4 micogram/ml/h-1
Standard Deviation 6.7
|
22.3 micogram/ml/h-1
Standard Deviation 13.4
|
34.5 micogram/ml/h-1
Standard Deviation 22.1
|
45.2 micogram/ml/h-1
Standard Deviation 29.0
|
7.4 micogram/ml/h-1
Standard Deviation 4.0
|
14.9 micogram/ml/h-1
Standard Deviation 8.0
|
22.3 micogram/ml/h-1
Standard Deviation 12.1
|
29.8 micogram/ml/h-1
Standard Deviation 15.7
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo Against T. Trichiura in PSAC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ALB 200 mg Against T. Trichiura in PSAC
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
ALB 400 mg Against T. Trichiura in PSAC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ALB 600 mg Against T. Trichiura in PSAC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Against T. Trichiura in SAC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ALB 400 mg Against T. Trichiura in SAC
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
ALB 600 mg Against T. Trichiura in SAC
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
ALB 800 mg Against T. Trichiura in SAC
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo Against T. Trichiura in Adults
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ALB 400 mg Against T. Trichiura in Adults
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ALB 600 mg Against T. Trichiura in Adults
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ALB 800 mg Against T. Trichiura in Adults
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Against Hookworm in PSAC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ALB 200 mg Against Hookworm in PSAC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ALB 400 mg Against Hookworm in PSAC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ALB 600 mg Against Hookworm in PSAC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Against Hookworm in SAC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ALB 200 mg Against Hookworm in SAC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ALB 400 mg Against Hookworm in SAC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ALB 600 mg Against Hookworm in SAC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ALB 800 mg Against Hookworm in SAC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Against Hookworm in Adults
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ALB 200 mg Against Hookworm in Adults
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ALB 400 mg Against Hookworm in Adults
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
ALB 600 mg Against Hookworm in Adults
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ALB 800 mg Against Hookworm in Adults
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Against T. Trichiura in PSAC
n=27 participants at risk
Placebo against T. trichiura in preschool-aged children
|
ALB 200 mg Against T. Trichiura in PSAC
n=27 participants at risk
200 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 400 mg Against T. Trichiura in PSAC
n=30 participants at risk
400 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 600 mg Against T. Trichiura in PSAC
n=27 participants at risk
600 mg of albendazole against T. trichiura in preschool-aged children
|
Placebo Against T. Trichiura in SAC
n=46 participants at risk
Placebo against T. trichiura in school-aged children
|
ALB 400 mg Against T. Trichiura in SAC
n=45 participants at risk
400 mg of albendazole against T. trichiura in school-aged children
|
ALB 600 mg Against T. Trichiura in SAC
n=46 participants at risk
600 mg of albendazole against T. trichiura in school-aged children
|
ALB 800 mg Against T. Trichiura in SAC
n=43 participants at risk
800 mg of albendazole against T. trichiura in school-aged children
|
Placebo Against T. Trichiura in Adults
n=10 participants at risk
Placebo against T. trichiura in adults
|
ALB 400 mg Against T. Trichiura in Adults
n=11 participants at risk
400 mg of albendazole against T. trichiura in adults
|
ALB 600 mg Against T. Trichiura in Adults
n=9 participants at risk
600 mg of albendazole against T. trichiura in adults
|
ALB 800 mg Against T. Trichiura in Adults
n=12 participants at risk
800 mg of albendazole against T. trichiura in adults
|
Placebo Against Hookworm in PSAC
Placebo against hookworm in preschool-aged children
|
ALB 200 mg Against Hookworm in PSAC
n=13 participants at risk
200 mg of albendazole against hookworm in preschool-aged children
|
ALB 400 mg Against Hookworm in PSAC
n=13 participants at risk
400 mg of albendazole against hookworm in preschool-aged children
|
ALB 600 mg Against Hookworm in PSAC
n=12 participants at risk
600 mg of albendazole against hookworm in preschool-aged children
|
Placebo Against Hookworm in SAC
n=24 participants at risk
Placebo against hookworm in school-aged children
|
ALB 200 mg Against Hookworm in SAC
n=27 participants at risk
200 mg of albendazole against hookworm in school-aged children
|
ALB 400 mg Against Hookworm in SAC
n=27 participants at risk
400 mg of albendazole against hookworm in school-aged children
|
ALB 600 mg Against Hookworm in SAC
n=29 participants at risk
600 mg of albendazole against hookworm in school-aged children
|
ALB 800 mg Against Hookworm in SAC
n=26 participants at risk
800 mg of albendazole against hookworm in school-aged children
|
Placebo Against Hookworm in Adults
n=40 participants at risk
Placebo against hookworm in adults
|
ALB 200 mg Against Hookworm in Adults
n=41 participants at risk
200 mg of albendazole against hookworm in adults
|
ALB 400 mg Against Hookworm in Adults
n=38 participants at risk
400 mg of albendazole against hookworm in adults
|
ALB 600 mg Against Hookworm in Adults
n=40 participants at risk
600 mg of albendazole against hookworm in adults
|
ALB 800 mg Against Hookworm in Adults
n=37 participants at risk
800 mg of albendazole against hookworm in adults
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Inpatient hospitalization due to clinical malaria
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
3.7%
1/27 • Number of events 1 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/30 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/46 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/45 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/46 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/43 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/10 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/11 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/9 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/12 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
—
0/0 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/13 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/13 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/12 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/24 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/29 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/26 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/40 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/41 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/38 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/40 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/37 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
Other adverse events
| Measure |
Placebo Against T. Trichiura in PSAC
n=27 participants at risk
Placebo against T. trichiura in preschool-aged children
|
ALB 200 mg Against T. Trichiura in PSAC
n=27 participants at risk
200 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 400 mg Against T. Trichiura in PSAC
n=30 participants at risk
400 mg of albendazole against T. trichiura in preschool-aged children
|
ALB 600 mg Against T. Trichiura in PSAC
n=27 participants at risk
600 mg of albendazole against T. trichiura in preschool-aged children
|
Placebo Against T. Trichiura in SAC
n=46 participants at risk
Placebo against T. trichiura in school-aged children
|
ALB 400 mg Against T. Trichiura in SAC
n=45 participants at risk
400 mg of albendazole against T. trichiura in school-aged children
|
ALB 600 mg Against T. Trichiura in SAC
n=46 participants at risk
600 mg of albendazole against T. trichiura in school-aged children
|
ALB 800 mg Against T. Trichiura in SAC
n=43 participants at risk
800 mg of albendazole against T. trichiura in school-aged children
|
Placebo Against T. Trichiura in Adults
n=10 participants at risk
Placebo against T. trichiura in adults
|
ALB 400 mg Against T. Trichiura in Adults
n=11 participants at risk
400 mg of albendazole against T. trichiura in adults
|
ALB 600 mg Against T. Trichiura in Adults
n=9 participants at risk
600 mg of albendazole against T. trichiura in adults
|
ALB 800 mg Against T. Trichiura in Adults
n=12 participants at risk
800 mg of albendazole against T. trichiura in adults
|
Placebo Against Hookworm in PSAC
Placebo against hookworm in preschool-aged children
|
ALB 200 mg Against Hookworm in PSAC
n=13 participants at risk
200 mg of albendazole against hookworm in preschool-aged children
|
ALB 400 mg Against Hookworm in PSAC
n=13 participants at risk
400 mg of albendazole against hookworm in preschool-aged children
|
ALB 600 mg Against Hookworm in PSAC
n=12 participants at risk
600 mg of albendazole against hookworm in preschool-aged children
|
Placebo Against Hookworm in SAC
n=24 participants at risk
Placebo against hookworm in school-aged children
|
ALB 200 mg Against Hookworm in SAC
n=27 participants at risk
200 mg of albendazole against hookworm in school-aged children
|
ALB 400 mg Against Hookworm in SAC
n=27 participants at risk
400 mg of albendazole against hookworm in school-aged children
|
ALB 600 mg Against Hookworm in SAC
n=29 participants at risk
600 mg of albendazole against hookworm in school-aged children
|
ALB 800 mg Against Hookworm in SAC
n=26 participants at risk
800 mg of albendazole against hookworm in school-aged children
|
Placebo Against Hookworm in Adults
n=40 participants at risk
Placebo against hookworm in adults
|
ALB 200 mg Against Hookworm in Adults
n=41 participants at risk
200 mg of albendazole against hookworm in adults
|
ALB 400 mg Against Hookworm in Adults
n=38 participants at risk
400 mg of albendazole against hookworm in adults
|
ALB 600 mg Against Hookworm in Adults
n=40 participants at risk
600 mg of albendazole against hookworm in adults
|
ALB 800 mg Against Hookworm in Adults
n=37 participants at risk
800 mg of albendazole against hookworm in adults
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
7.4%
2/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
10.0%
3/30 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
6.5%
3/46 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
2.2%
1/45 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
6.5%
3/46 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
11.6%
5/43 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
10.0%
1/10 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
27.3%
3/11 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
22.2%
2/9 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
16.7%
2/12 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
—
0/0 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
7.7%
1/13 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/13 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
8.3%
1/12 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
4.2%
1/24 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
3.7%
1/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/29 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/26 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
5.0%
2/40 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
7.3%
3/41 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
10.5%
4/38 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
5.0%
2/40 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
2.7%
1/37 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
1/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
3.3%
1/30 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
7.4%
2/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
8.7%
4/46 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
8.9%
4/45 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
6.5%
3/46 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
16.3%
7/43 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
20.0%
2/10 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
27.3%
3/11 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
11.1%
1/9 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/12 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
—
0/0 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/13 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/13 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/12 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
4.2%
1/24 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
7.4%
2/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
7.4%
2/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
3.4%
1/29 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
11.5%
3/26 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/40 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
2.4%
1/41 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
2.6%
1/38 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
5.0%
2/40 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
8.1%
3/37 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/30 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/46 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/45 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/46 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/43 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/10 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
9.1%
1/11 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/9 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/12 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
—
0/0 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/13 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/13 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/12 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/24 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/29 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/26 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/40 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/41 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/38 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/40 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
2.7%
1/37 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/30 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
2.2%
1/46 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/45 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/46 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/43 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/10 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/11 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/9 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/12 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
—
0/0 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/13 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/13 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/12 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/24 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/29 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/26 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/40 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/41 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/38 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/40 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/37 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
|
Infections and infestations
Diarrhea
|
3.7%
1/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
6.7%
2/30 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
3.7%
1/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
4.3%
2/46 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
6.7%
3/45 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
2.2%
1/46 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/43 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/10 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/11 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/9 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/12 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
—
0/0 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/13 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/13 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/12 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/24 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/29 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/26 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/40 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/41 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/38 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/40 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/37 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/30 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/46 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
2.2%
1/45 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
2.2%
1/46 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/43 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/10 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/11 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/9 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
8.3%
1/12 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
—
0/0 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/13 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/13 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/12 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/24 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/27 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/29 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/26 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/40 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/41 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/38 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/40 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
0.00%
0/37 • Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
|
Additional Information
Jennifer Keiser, PhD
Swiss Tropical and Public Health Institute
Phone: +41 (61) 284 8218
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place