Trial Outcomes & Findings for Efficacy and Safety of MOX/ALB vs. IVM/ALB Co-administration (NCT NCT04700423)
NCT ID: NCT04700423
Last Updated: 2024-12-05
Results Overview
Egg reduction rate is calculated as the relative reduction in the group geometric mean egg output after co-administration of moxidectin/ albendazole and ivermectin/ albendazole assessed at 14-21 days post-treatment compared to the baseline levels.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
536 participants
Primary outcome timeframe
14-21 day post-treatment
Results posted on
2024-12-05
Participant Flow
Participant milestones
| Measure |
A: Moxidectin (8 mg) / Albendazole (400 mg)
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
D: Ivermectin (200 µg/kg)
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
|---|---|---|---|---|---|
|
Baseline/Treatment
STARTED
|
207
|
211
|
19
|
19
|
80
|
|
Baseline/Treatment
COMPLETED
|
207
|
211
|
19
|
19
|
80
|
|
Baseline/Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up 1: 14-21 Days Post Treatment
STARTED
|
207
|
211
|
19
|
19
|
80
|
|
Follow-up 1: 14-21 Days Post Treatment
COMPLETED
|
207
|
211
|
19
|
19
|
80
|
|
Follow-up 1: 14-21 Days Post Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up 2: 5-6 Weeks Post Treatment
STARTED
|
207
|
211
|
19
|
19
|
80
|
|
Follow-up 2: 5-6 Weeks Post Treatment
COMPLETED
|
206
|
211
|
18
|
19
|
80
|
|
Follow-up 2: 5-6 Weeks Post Treatment
NOT COMPLETED
|
1
|
0
|
1
|
0
|
0
|
|
Follow-up 3: 3 Months Post Treatment
STARTED
|
206
|
211
|
18
|
19
|
80
|
|
Follow-up 3: 3 Months Post Treatment
COMPLETED
|
201
|
210
|
18
|
18
|
77
|
|
Follow-up 3: 3 Months Post Treatment
NOT COMPLETED
|
5
|
1
|
0
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=207 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=211 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=19 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
D: Ivermectin (200 µg/kg)
n=19 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=80 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
Total
n=536 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
15.8 years
STANDARD_DEVIATION 1.5 • n=207 Participants
|
15.8 years
STANDARD_DEVIATION 1.5 • n=211 Participants
|
15.6 years
STANDARD_DEVIATION 1.2 • n=19 Participants
|
15.9 years
STANDARD_DEVIATION 1.3 • n=19 Participants
|
15.8 years
STANDARD_DEVIATION 1.4 • n=80 Participants
|
15.8 years
STANDARD_DEVIATION 1.5 • n=536 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=207 Participants
|
163 Participants
n=211 Participants
|
13 Participants
n=19 Participants
|
16 Participants
n=19 Participants
|
54 Participants
n=80 Participants
|
394 Participants
n=536 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=207 Participants
|
48 Participants
n=211 Participants
|
6 Participants
n=19 Participants
|
3 Participants
n=19 Participants
|
26 Participants
n=80 Participants
|
142 Participants
n=536 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Height, cm
|
157.1 cm
STANDARD_DEVIATION 7.4 • n=207 Participants
|
157.2 cm
STANDARD_DEVIATION 7.3 • n=211 Participants
|
159.1 cm
STANDARD_DEVIATION 7.8 • n=19 Participants
|
158.9 cm
STANDARD_DEVIATION 7.1 • n=19 Participants
|
157.4 cm
STANDARD_DEVIATION 6.8 • n=80 Participants
|
157.3 cm
STANDARD_DEVIATION 7.3 • n=536 Participants
|
|
Weight, kg
|
48.3 kg
STANDARD_DEVIATION 8.3 • n=207 Participants
|
47.7 kg
STANDARD_DEVIATION 8.2 • n=211 Participants
|
50.8 kg
STANDARD_DEVIATION 7.8 • n=19 Participants
|
48.1 kg
STANDARD_DEVIATION 6.1 • n=19 Participants
|
47.1 kg
STANDARD_DEVIATION 6.5 • n=80 Participants
|
48.0 kg
STANDARD_DEVIATION 7.9 • n=536 Participants
|
|
T. trichiura infection, geometric mean EPG
|
450 eggs per gram
STANDARD_DEVIATION 4 • n=207 Participants
|
468 eggs per gram
STANDARD_DEVIATION 4 • n=211 Participants
|
421 eggs per gram
STANDARD_DEVIATION 4 • n=19 Participants
|
573 eggs per gram
STANDARD_DEVIATION 4 • n=19 Participants
|
481 eggs per gram
STANDARD_DEVIATION 3 • n=80 Participants
|
463 eggs per gram
STANDARD_DEVIATION 4 • n=536 Participants
|
|
T. trichiura infection, arithmetic mean EPG
|
975 eggs per gram
STANDARD_DEVIATION 1329 • n=207 Participants
|
1045 eggs per gram
STANDARD_DEVIATION 1509 • n=211 Participants
|
1014 eggs per gram
STANDARD_DEVIATION 1504 • n=19 Participants
|
1670 eggs per gram
STANDARD_DEVIATION 3243 • n=19 Participants
|
935 eggs per gram
STANDARD_DEVIATION 1435 • n=80 Participants
|
1022 eggs per gram
STANDARD_DEVIATION 1525 • n=536 Participants
|
|
T. trichiura infection intensity (EPG): light
|
144 Participants
n=207 Participants
|
148 Participants
n=211 Participants
|
14 Participants
n=19 Participants
|
14 Participants
n=19 Participants
|
57 Participants
n=80 Participants
|
377 Participants
n=536 Participants
|
|
T. trichiura infection intensity (EPG): moderate
|
63 Participants
n=207 Participants
|
63 Participants
n=211 Participants
|
5 Participants
n=19 Participants
|
4 Participants
n=19 Participants
|
23 Participants
n=80 Participants
|
158 Participants
n=536 Participants
|
|
T. trichiura infection intensity (EPG): heavy
|
0 Participants
n=207 Participants
|
0 Participants
n=211 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=80 Participants
|
1 Participants
n=536 Participants
|
|
Hookworm infection, No. infected
|
64 Participants
n=207 Participants • number of infected participants
|
70 Participants
n=211 Participants • number of infected participants
|
3 Participants
n=19 Participants • number of infected participants
|
8 Participants
n=19 Participants • number of infected participants
|
28 Participants
n=80 Participants • number of infected participants
|
173 Participants
n=536 Participants • number of infected participants
|
|
Hookworm infection, geometric mean EPG
|
125 eggs per gram
STANDARD_DEVIATION 4 • n=64 Participants • number of infected participants
|
112 eggs per gram
STANDARD_DEVIATION 4 • n=70 Participants • number of infected participants
|
128 eggs per gram
STANDARD_DEVIATION 8 • n=3 Participants • number of infected participants
|
94 eggs per gram
STANDARD_DEVIATION 5 • n=8 Participants • number of infected participants
|
89 eggs per gram
STANDARD_DEVIATION 3 • n=28 Participants • number of infected participants
|
111 eggs per gram
STANDARD_DEVIATION 4 • n=173 Participants • number of infected participants
|
|
Hookworm infection, arithmetic mean EPG
|
261 eggs per gram
STANDARD_DEVIATION 332 • n=64 Participants • number of infected participants
|
261 eggs per gram
STANDARD_DEVIATION 385 • n=70 Participants • number of infected participants
|
428 eggs per gram
STANDARD_DEVIATION 644 • n=3 Participants • number of infected participants
|
200 eggs per gram
STANDARD_DEVIATION 208 • n=8 Participants • number of infected participants
|
150 eggs per gram
STANDARD_DEVIATION 175 • n=28 Participants • number of infected participants
|
243 eggs per gram
STANDARD_DEVIATION 337 • n=173 Participants • number of infected participants
|
|
Hookworm infection intensity (EPG): light
|
64 Participants
n=64 Participants • Row population is the count of participants infected with Hookworm
|
70 Participants
n=70 Participants • Row population is the count of participants infected with Hookworm
|
3 Participants
n=3 Participants • Row population is the count of participants infected with Hookworm
|
8 Participants
n=8 Participants • Row population is the count of participants infected with Hookworm
|
28 Participants
n=28 Participants • Row population is the count of participants infected with Hookworm
|
173 Participants
n=173 Participants • Row population is the count of participants infected with Hookworm
|
|
A. lumbricoides infection, No. infected
|
106 Participants
n=207 Participants
|
110 Participants
n=211 Participants
|
12 Participants
n=19 Participants
|
14 Participants
n=19 Participants
|
50 Participants
n=80 Participants
|
292 Participants
n=536 Participants
|
|
A. lumbricoides infection, geometric mean EPG
|
7819 eggs per gram
STANDARD_DEVIATION 4 • n=106 Participants • number of infected participants
|
5934 eggs per gram
STANDARD_DEVIATION 5 • n=110 Participants • number of infected participants
|
8512 eggs per gram
STANDARD_DEVIATION 4 • n=12 Participants • number of infected participants
|
4724 eggs per gram
STANDARD_DEVIATION 4 • n=14 Participants • number of infected participants
|
6765 eggs per gram
STANDARD_DEVIATION 4 • n=50 Participants • number of infected participants
|
6728 eggs per gram
STANDARD_DEVIATION 4 • n=292 Participants • number of infected participants
|
|
A. lumbricoides infection, arithmetic mean EPG
|
15823 eggs per gram
STANDARD_DEVIATION 18844 • n=106 Participants • number of infected participants
|
14284 eggs per gram
STANDARD_DEVIATION 20566 • n=110 Participants • number of infected participants
|
17062 eggs per gram
STANDARD_DEVIATION 19533 • n=12 Participants • number of infected participants
|
9821 eggs per gram
STANDARD_DEVIATION 9162 • n=14 Participants • number of infected participants
|
11969 eggs per gram
STANDARD_DEVIATION 12883 • n=50 Participants • number of infected participants
|
14247 eggs per gram
STANDARD_DEVIATION 18323 • n=292 Participants • number of infected participants
|
|
A. lumbricoides intensity (EPG): light
|
39 Participants
n=106 Participants • Row population is the count of participants infected with A. lumbricoides
|
49 Participants
n=110 Participants • Row population is the count of participants infected with A. lumbricoides
|
4 Participants
n=12 Participants • Row population is the count of participants infected with A. lumbricoides
|
7 Participants
n=14 Participants • Row population is the count of participants infected with A. lumbricoides
|
17 Participants
n=50 Participants • Row population is the count of participants infected with A. lumbricoides
|
116 Participants
n=292 Participants • Row population is the count of participants infected with A. lumbricoides
|
|
A. lumbricoides infection intensity (EPG): moderate
|
61 Participants
n=106 Participants • Row population is the count of participants infected with A. lumbricoides
|
55 Participants
n=110 Participants • Row population is the count of participants infected with A. lumbricoides
|
7 Participants
n=12 Participants • Row population is the count of participants infected with A. lumbricoides
|
7 Participants
n=14 Participants • Row population is the count of participants infected with A. lumbricoides
|
32 Participants
n=50 Participants • Row population is the count of participants infected with A. lumbricoides
|
162 Participants
n=292 Participants • Row population is the count of participants infected with A. lumbricoides
|
|
A. lumbricoides infection intensity (EPG): heavy
|
6 Participants
n=106 Participants • Row population is the count of participants infected with A. lumbricoides
|
6 Participants
n=110 Participants • Row population is the count of participants infected with A. lumbricoides
|
1 Participants
n=12 Participants • Row population is the count of participants infected with A. lumbricoides
|
0 Participants
n=14 Participants • Row population is the count of participants infected with A. lumbricoides
|
1 Participants
n=50 Participants • Row population is the count of participants infected with A. lumbricoides
|
14 Participants
n=292 Participants • Row population is the count of participants infected with A. lumbricoides
|
PRIMARY outcome
Timeframe: 14-21 day post-treatmentPopulation: Geometric mean reduction in number of eggs at baseline and assessed at 14-21 days post-treatment
Egg reduction rate is calculated as the relative reduction in the group geometric mean egg output after co-administration of moxidectin/ albendazole and ivermectin/ albendazole assessed at 14-21 days post-treatment compared to the baseline levels.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=19 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=80 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=207 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=211 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=19 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Egg Reduction Rate Against T. Trichiura
|
94.2 Percent change
Interval 89.3 to 97.1
|
85.5 Percent change
Interval 79.7 to 89.8
|
96.8 Percent change
Interval 95.8 to 97.6
|
99.0 Percent change
Interval 98.7 to 99.3
|
86.2 Percent change
Interval 61.8 to 95.6
|
SECONDARY outcome
Timeframe: 3 hours, 24 hours, 14-21 days, 5-6 weeks and 3 months post-treatmentPopulation: number analyzed corresponds to the number of participants assessed per time point
The observation time for AE starts when the treatment is initiated. Subjects will be kept for observation for at least 3 hours following treatment for any acute AE and. If there is any abnormal finding, the local study physician will perform a full clinical examination and findings will be recorded. An emergency kit will be available on site to treat any medical conditions that warrant urgent medical intervention. Participants will also be interviewed at 3h and 24h as well as retrospectively 14 -21 days, 5-6 weeks and 3 months after treatment about the occurrence of AEs.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=19 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=80 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=207 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=211 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=19 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
Baseline
|
0 Participants
|
0 Participants
|
7 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
3h post treatment
|
2 Participants
|
6 Participants
|
17 Participants
|
25 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
24h post treatment
|
2 Participants
|
6 Participants
|
36 Participants
|
40 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events
14 to 21 days post treatment
|
4 Participants
|
13 Participants
|
35 Participants
|
41 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events
5 to 6 weeks post treatment
|
2 Participants
|
6 Participants
|
20 Participants
|
10 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
3 months post treatment
|
2 Participants
|
4 Participants
|
10 Participants
|
15 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14-21 day post-treatmentAssessment of superiority in terms of CRs of the drug combinations compared to their corresponding monotherapies: Arm C: Albendazole (400 mg) Arm D: Ivermectin (200 μg/kg) and Arm E: Moxidectin (8 mg). Cure rates is defined as the percentages of participants treated with Moxidectin (8 mg)/Albendazole (400 mg), Ivermectin (200 μg/kg)/Albendazole (400 mg), Albendazole (400 mg), Ivermectin (200 μg/kg) or Moxidectin (8 mg) who were cured of infections with T. trichiura.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=19 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=80 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=207 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=211 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=19 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Superiority in Terms of Cure Rates (CRs)
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
11.2 Percentage of participants
Interval 5.3 to 20.3
|
34.3 Percentage of participants
Interval 27.9 to 41.2
|
54.0 Percentage of participants
Interval 47.1 to 60.9
|
26.3 Percentage of participants
Interval 9.1 to 51.2
|
SECONDARY outcome
Timeframe: 14-21 day post-treatmentPopulation: Number of participants found positive for hookworm at 14-21 days post-treatment
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=19 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=80 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=207 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=211 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=19 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Cure Rates Against T. Trichiura
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
11.2 Percentage of participants
Interval 5.3 to 20.3
|
34.3 Percentage of participants
Interval 27.9 to 41.2
|
54.0 Percentage of participants
Interval 47.1 to 60.9
|
26.3 Percentage of participants
Interval 9.1 to 51.2
|
SECONDARY outcome
Timeframe: 5-6 weeks post-treatmentPopulation: Geometric mean reduction in number of eggs at baseline and assessed at 5-6 weeks post-treatment
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=19 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=80 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=206 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=211 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=18 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks
|
76.9 Percent change
Interval 65.6 to 84.7
|
85.4 Percent change
Interval 77.6 to 90.7
|
97.0 Percent change
Interval 96.0 to 97.8
|
98.3 Percent change
Interval 97.6 to 98.7
|
75.7 Percent change
Interval 40.8 to 90.5
|
SECONDARY outcome
Timeframe: 5-6 weeks post-treatmentPopulation: Number of participants found positive for hookworm at 5-6 weeks post-treatment
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=19 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=80 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=206 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=211 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=18 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks
|
0.0 Percentage of participants
Interval 0.0 to 17.6
|
11.2 Percentage of participants
Interval 5.3 to 20.3
|
37.4 Percentage of participants
Interval 30.8 to 44.4
|
46.4 Percentage of participants
Interval 39.6 to 53.4
|
16.7 Percentage of participants
Interval 3.6 to 41.4
|
SECONDARY outcome
Timeframe: 3 months post-treatmentPopulation: Geometric mean reduction in number of eggs at baseline and assessed at 3 months post-treatment
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=18 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=77 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=201 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=210 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=18 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 3 Months
|
55.4 Percent change
Interval 22.3 to 74.2
|
71.9 Percent change
Interval 58.9 to 81.4
|
93.2 Percent change
Interval 90.8 to 95.0
|
97.1 Percent change
Interval 96.1 to 97.9
|
78.2 Percent change
Interval 55.5 to 90.0
|
SECONDARY outcome
Timeframe: 3 months post-treatmentPopulation: Number of participants found positive for T. trichiura at baseline and assessed at 3 months post-treatment
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=18 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=77 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=201 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=210 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=18 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Extended Effects (Cure Rates) on Follow-up of T. Trichiura: 3 Months
|
0.0 Percentage of participants
Interval 0.0 to 18.5
|
9.1 Percentage of participants
Interval 3.7 to 17.8
|
27.4 Percentage of participants
Interval 21.3 to 34.1
|
39.5 Percentage of participants
Interval 32.9 to 46.5
|
11.1 Percentage of participants
Interval 1.4 to 34.7
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Geometric mean reduction in number of eggs at baseline and assessed at 14-21 days post-treatment
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=8 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=28 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=64 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=70 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=3 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm
|
61.9 Percent change
Interval -8.0 to 86.8
|
81.2 Percent change
Interval 58.9 to 91.7
|
98.8 Percent change
Interval 97.6 to 99.4
|
97.4 Percent change
Interval 95.9 to 98.4
|
100.0 Percent change
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Number of participants found positive for hookworm at baseline and assessed at 14-21 days post-treatment
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=8 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=28 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=64 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=70 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=3 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm
|
25.0 Percentage of participants
Interval 3.2 to 65.1
|
32.1 Percentage of participants
Interval 15.9 to 52.4
|
75.0 Percentage of participants
Interval 62.6 to 85.0
|
62.9 Percentage of participants
Interval 50.5 to 74.1
|
100.0 Percentage of participants
Interval 29.2 to 100.0
|
SECONDARY outcome
Timeframe: 5-6 weeks post-treatmentPopulation: Mean number of participants found positive for hookworm at 5-6 weeks post-treatment
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=8 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=28 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=64 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=70 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=3 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 5-6 Weeks
|
57.9 Percent change
Interval -10.4 to 84.3
|
88.7 Percent change
Interval 71.0 to 95.9
|
98.6 Percent change
Interval 97.4 to 99.3
|
96.8 Percent change
Interval 94.9 to 98.1
|
94.6 Percent change
Interval 56.9 to 100.0
|
SECONDARY outcome
Timeframe: 5-6 weeks post-treatmentPopulation: Number of participants found positive for hookworm at 5-6 weeks post-treatment
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=8 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=28 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=64 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=70 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=3 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Extended Effects (Cure Rate) on Follow-up of Hookworm: 5-6 Weeks
|
25.0 Percentage of participants
Interval 3.2 to 65.1
|
42.9 Percentage of participants
Interval 24.5 to 62.8
|
71.9 Percentage of participants
Interval 59.2 to 82.4
|
61.4 Percentage of participants
Interval 49.0 to 72.8
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
SECONDARY outcome
Timeframe: 3 months post-treatmentPopulation: Geometric mean reduction in number of eggs at baseline and assessed at 3 months post-treatment
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=8 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=25 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=62 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=70 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=3 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 3 Months
|
56.1 Percent change
Interval -31.9 to 85.5
|
76.7 Percent change
Interval 39.3 to 92.0
|
97.6 Percent change
Interval 95.9 to 98.7
|
95.1 Percent change
Interval 91.5 to 97.3
|
96.3 Percent change
Interval 83.6 to 100.0
|
SECONDARY outcome
Timeframe: 3 months post-treatmentPopulation: Number of participants found positive for hookworm at 3 months post-treatment
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=8 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=25 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=62 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=70 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=3 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Extended Effects (Cure Rate) on Follow-up of Hookworm: 3 Months
|
25.0 Percentage of participants
Interval 3.2 to 65.1
|
32.0 Percentage of participants
Interval 14.9 to 53.5
|
66.1 Percentage of participants
Interval 53.0 to 77.7
|
60.0 Percentage of participants
Interval 47.6 to 71.5
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Geometric mean reduction in number of eggs at baseline and assessed at 14-21 days post-treatment
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=14 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=50 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=106 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=110 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=12 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides
|
100.0 Percent change
Interval 100.0 to 100.0
|
100.0 Percent change
Interval 100.0 to 100.0
|
100.0 Percent change
Interval 100.0 to 100.0
|
100.0 Percent change
Interval 100.0 to 100.0
|
100.0 Percent change
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Number of participants found positive for A. lumbricoides at baseline and assessed at 14-21 days post-treatment
Cure rates is defined as the percentages of participants treated with Moxidectin (8 mg)/Albendazole (400 mg), Ivermectin (200 μg/kg)/Albendazole (400 mg), Albendazole (400 mg), Ivermectin (200 μg/kg) or Moxidectin (8 mg) who were cured of infections with A. lumbricoides.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=14 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=50 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=106 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=110 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=12 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides
|
100.0 Percentage of participants
Interval 76.8 to 100.0
|
98.0 Percentage of participants
Interval 89.4 to 99.9
|
100.0 Percentage of participants
Interval 96.6 to 100.0
|
96.4 Percentage of participants
Interval 91.0 to 99.0
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
SECONDARY outcome
Timeframe: 5-6 weeks post-treatmentPopulation: Geometric mean reduction in number of eggs at baseline and assessed at 5-6 weeks post-treatment
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=14 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=50 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=106 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=110 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=12 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks
|
100.0 Percent change
Interval 100.0 to 100.0
|
100.0 Percent change
Interval 100.0 to 100.0
|
100.0 Percent change
Interval 100.0 to 100.0
|
100.0 Percent change
Interval 100.0 to 100.0
|
100.0 Percent change
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 5-6 weeks post-treatmentPopulation: Number of participants found positive for hookworm at 5-6 weeks post-treatment
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=14 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=50 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=106 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=110 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=12 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
98.0 Percentage of participants
Interval 89.4 to 99.9
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 3 months post-treatmentPopulation: Geometric mean reduction in number of eggs at baseline and assessed at 3 months post-treatment
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=14 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=48 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=102 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=110 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=12 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 3 Months
|
100.0 Percent change
Interval 99.9 to 100.0
|
100.0 Percent change
Interval 99.9 to 100.0
|
100.0 Percent change
Interval 100.0 to 100.0
|
100.0 Percent change
Interval 100.0 to 100.0
|
100.0 Percent change
Interval 99.9 to 100.0
|
SECONDARY outcome
Timeframe: 3 months post-treatmentPopulation: Number of participants found positive for hookworm at 3 months post-treatment
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Outcome measures
| Measure |
D: Ivermectin (200 µg/kg)
n=14 Participants
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=48 Participants
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=102 Participants
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=110 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=12 Participants
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
|---|---|---|---|---|---|
|
Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 3 Months
|
92.9 Percentage of participants
Interval 66.1 to 99.8
|
87.5 Percentage of participants
Interval 74.8 to 95.3
|
87.3 Percentage of participants
Interval 79.2 to 93.0
|
88.2 Percentage of participants
Interval 80.6 to 93.6
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
Adverse Events
A: Moxidectin (8 mg) / Albendazole (400 mg)
Serious events: 0 serious events
Other events: 73 other events
Deaths: 0 deaths
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
Serious events: 0 serious events
Other events: 93 other events
Deaths: 0 deaths
C: Albendazole (400 mg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
D: Ivermectin (200 µg/kg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
E: Moxidectin (8 mg)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A: Moxidectin (8 mg) / Albendazole (400 mg)
n=207 participants at risk
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)
n=211 participants at risk
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
C: Albendazole (400 mg)
n=19 participants at risk
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
|
D: Ivermectin (200 µg/kg)
n=19 participants at risk
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
|
E: Moxidectin (8 mg)
n=80 participants at risk
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
|
|---|---|---|---|---|---|
|
General disorders
Headache
|
14.5%
30/207 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
18.0%
38/211 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
15.8%
3/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
10.5%
2/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
7.5%
6/80 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
|
General disorders
Abdominal pain
|
6.3%
13/207 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
7.6%
16/211 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
5.3%
1/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
5.3%
1/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
5.0%
4/80 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
|
General disorders
Itching
|
1.9%
4/207 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
3.8%
8/211 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
5.3%
1/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
1.2%
1/80 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
|
General disorders
Dizziness
|
0.48%
1/207 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
1.4%
3/211 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
1.2%
1/80 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
|
General disorders
Musculoskeletal pain
|
2.9%
6/207 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
2.8%
6/211 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
5.3%
1/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
3.8%
3/80 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
|
General disorders
Muscle weakness
|
2.9%
6/207 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
4.3%
9/211 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
5.0%
4/80 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
|
General disorders
Rash
|
0.97%
2/207 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
1.9%
4/211 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
5.3%
1/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/80 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
|
General disorders
Nausea
|
1.4%
3/207 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
1.4%
3/211 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
1.2%
1/80 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
|
General disorders
Diarrhea
|
0.48%
1/207 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
2.4%
5/211 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
1.2%
1/80 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
|
General disorders
Cough
|
0.00%
0/207 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/211 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/80 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
|
General disorders
Constipation
|
1.4%
3/207 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.47%
1/211 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/80 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
|
General disorders
Vomiting
|
0.48%
1/207 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/211 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
2.5%
2/80 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
|
General disorders
Other
|
1.4%
3/207 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/211 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/19 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
0.00%
0/80 • Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place