Trial Outcomes & Findings for Efficacy, Safety and Acceptability of Ivermectin ODT in PSAC (NCT NCT06184399)
NCT ID: NCT06184399
Last Updated: 2025-09-22
Results Overview
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
260 participants
Primary outcome timeframe
14-21 days post-treatment
Results posted on
2025-09-22
Participant Flow
Participant milestones
| Measure |
Arm A: Ivermectin ODT Placebo & Albendazole
Placebo for ivermectin (oro-dispersible tablets, ODT) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Ivermectin ODT: Placebo for ivermectin ODT
|
Arm B: Ivermectin ODT 100 µg/kg & Albendazole
Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin ODT 200 µg/kg & Albendazole
Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm D: Ivermectin ODT 300 µg/kg & Albendazole
Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm E: Ivermectin ODT 400 µg/kg & Albendazole
Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm F: Ivermectin Standard Tablets & Albendazole
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
44
|
42
|
44
|
44
|
43
|
|
Overall Study
COMPLETED
|
40
|
42
|
42
|
39
|
40
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
0
|
5
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm A: Ivermectin ODT Placebo & Albendazole
n=43 Participants
Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Ivermectin ODT: Placebo for ivermectin ODT
|
Arm B: Ivermectin ODT 100 µg/kg & Albendazole
n=44 Participants
Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin ODT 200 µg/kg & Albendazole
n=42 Participants
Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm D: Ivermectin ODT 300 µg/kg & Albendazole
n=44 Participants
Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm E: Ivermectin ODT 400 µg/kg & Albendazole
n=44 Participants
Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm F: Ivermectin Standard Tablets & Albendazole
n=43 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
3.7 years
STANDARD_DEVIATION 1.1 • n=43 Participants
|
3.6 years
STANDARD_DEVIATION 1.1 • n=44 Participants
|
3.5 years
STANDARD_DEVIATION 1.0 • n=42 Participants
|
3.6 years
STANDARD_DEVIATION 1.0 • n=44 Participants
|
3.5 years
STANDARD_DEVIATION 1.0 • n=44 Participants
|
3.7 years
STANDARD_DEVIATION 1.2 • n=43 Participants
|
3.6 years
STANDARD_DEVIATION 1.1 • n=260 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=43 Participants
|
20 Participants
n=44 Participants
|
24 Participants
n=42 Participants
|
24 Participants
n=44 Participants
|
21 Participants
n=44 Participants
|
26 Participants
n=43 Participants
|
137 Participants
n=260 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=43 Participants
|
24 Participants
n=44 Participants
|
18 Participants
n=42 Participants
|
20 Participants
n=44 Participants
|
23 Participants
n=44 Participants
|
17 Participants
n=43 Participants
|
123 Participants
n=260 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Tanzania
|
43 participants
n=43 Participants
|
44 participants
n=44 Participants
|
42 participants
n=42 Participants
|
44 participants
n=44 Participants
|
44 participants
n=44 Participants
|
43 participants
n=43 Participants
|
260 participants
n=260 Participants
|
|
Trichuris trichiura infection intensity
Light (<1000 EPG)
|
36 Participants
n=43 Participants
|
36 Participants
n=44 Participants
|
34 Participants
n=42 Participants
|
35 Participants
n=44 Participants
|
36 Participants
n=44 Participants
|
34 Participants
n=43 Participants
|
211 Participants
n=260 Participants
|
|
Trichuris trichiura infection intensity
Moderate (1000-9999 EPG)
|
7 Participants
n=43 Participants
|
8 Participants
n=44 Participants
|
7 Participants
n=42 Participants
|
9 Participants
n=44 Participants
|
8 Participants
n=44 Participants
|
9 Participants
n=43 Participants
|
48 Participants
n=260 Participants
|
|
Trichuris trichiura infection intensity
Heavy (>9999 EPG)
|
0 Participants
n=43 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=43 Participants
|
1 Participants
n=260 Participants
|
|
Ascaris lumbricoides co-infection
|
10 Participants
n=43 Participants
|
13 Participants
n=44 Participants
|
8 Participants
n=42 Participants
|
7 Participants
n=44 Participants
|
9 Participants
n=44 Participants
|
9 Participants
n=43 Participants
|
56 Participants
n=260 Participants
|
|
Hookworm co-infection
|
8 Participants
n=43 Participants
|
11 Participants
n=44 Participants
|
8 Participants
n=42 Participants
|
10 Participants
n=44 Participants
|
8 Participants
n=44 Participants
|
7 Participants
n=43 Participants
|
52 Participants
n=260 Participants
|
PRIMARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Available case population
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Outcome measures
| Measure |
Arm A: Ivermectin ODT Placebo & Albendazole
n=40 Participants
Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Ivermectin ODT: Placebo for ivermectin ODT
|
Arm B: Ivermectin ODT 100 µg/kg & Albendazole
n=42 Participants
Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin ODT 200 µg/kg & Albendazole
n=42 Participants
Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm D: Ivermectin ODT 300 µg/kg & Albendazole
n=39 Participants
Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm E: Ivermectin ODT 400 µg/kg & Albendazole
n=40 Participants
Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm F: Ivermectin Standard Tablets & Albendazole
n=42 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
|---|---|---|---|---|---|---|
|
Cure Rate (CR) Against T. Trichiura
|
17.5 percentage of participants cured (%)
Interval 7.3 to 32.8
|
50.0 percentage of participants cured (%)
Interval 34.2 to 65.8
|
83.3 percentage of participants cured (%)
Interval 68.6 to 93.0
|
84.6 percentage of participants cured (%)
Interval 69.5 to 94.1
|
90.0 percentage of participants cured (%)
Interval 76.3 to 97.2
|
73.8 percentage of participants cured (%)
Interval 58.0 to 86.1
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Available case population.
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 |
Arm A: Ivermectin ODT Placebo & Albendazole
n=40 Participants
Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Ivermectin ODT: Placebo for ivermectin ODT
|
Arm B: Ivermectin ODT 100 µg/kg & Albendazole
n=42 Participants
Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin ODT 200 µg/kg & Albendazole
n=42 Participants
Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm D: Ivermectin ODT 300 µg/kg & Albendazole
n=39 Participants
Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm E: Ivermectin ODT 400 µg/kg & Albendazole
n=40 Participants
Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm F: Ivermectin Standard Tablets & Albendazole
n=42 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
|---|---|---|---|---|---|---|
|
Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR)
|
65.5 percent change in egg counts (%)
Interval 30.5 to 83.5
|
97.2 percent change in egg counts (%)
Interval 93.9 to 98.8
|
99.7 percent change in egg counts (%)
Interval 99.2 to 99.9
|
99.7 percent change in egg counts (%)
Interval 99.1 to 99.9
|
99.8 percent change in egg counts (%)
Interval 99.5 to 100.0
|
99.2 percent change in egg counts (%)
Interval 97.9 to 99.8
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Available case population.
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 |
Arm A: Ivermectin ODT Placebo & Albendazole
n=40 Participants
Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Ivermectin ODT: Placebo for ivermectin ODT
|
Arm B: Ivermectin ODT 100 µg/kg & Albendazole
n=42 Participants
Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin ODT 200 µg/kg & Albendazole
n=42 Participants
Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm D: Ivermectin ODT 300 µg/kg & Albendazole
n=39 Participants
Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm E: Ivermectin ODT 400 µg/kg & Albendazole
n=40 Participants
Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm F: Ivermectin Standard Tablets & Albendazole
n=42 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
|---|---|---|---|---|---|---|
|
Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR)
|
30.2 percent change in egg counts (%)
Interval -11.0 to 54.2
|
88.3 percent change in egg counts (%)
Interval 79.6 to 94.3
|
98.9 percent change in egg counts (%)
Interval 96.8 to 99.7
|
97.9 percent change in egg counts (%)
Interval 94.4 to 99.6
|
98.3 percent change in egg counts (%)
Interval 95.6 to 99.9
|
79.8 percent change in egg counts (%)
Interval 38.7 to 97.2
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Subset of participants co-infected with A. lumbricoides at baseline and providing follow-up data.
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Outcome measures
| Measure |
Arm A: Ivermectin ODT Placebo & Albendazole
n=10 Participants
Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Ivermectin ODT: Placebo for ivermectin ODT
|
Arm B: Ivermectin ODT 100 µg/kg & Albendazole
n=13 Participants
Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin ODT 200 µg/kg & Albendazole
n=8 Participants
Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm D: Ivermectin ODT 300 µg/kg & Albendazole
n=7 Participants
Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm E: Ivermectin ODT 400 µg/kg & Albendazole
n=7 Participants
Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm F: Ivermectin Standard Tablets & Albendazole
n=9 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
|---|---|---|---|---|---|---|
|
Cure Rate (CR) Against A. Lumbricoides
|
100.0 percentage of participants cured (%)
Interval 69.2 to 100.0
|
100.0 percentage of participants cured (%)
Interval 75.3 to 100.0
|
100.0 percentage of participants cured (%)
Interval 63.1 to 100.0
|
100.0 percentage of participants cured (%)
Interval 59.0 to 100.0
|
100.0 percentage of participants cured (%)
Interval 59.0 to 100.0
|
100.0 percentage of participants cured (%)
Interval 66.4 to 100.0
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Subset of participants co-infected with A. lumbricoides at baseline and providing follow-up data.
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 |
Arm A: Ivermectin ODT Placebo & Albendazole
n=10 Participants
Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Ivermectin ODT: Placebo for ivermectin ODT
|
Arm B: Ivermectin ODT 100 µg/kg & Albendazole
n=13 Participants
Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin ODT 200 µg/kg & Albendazole
n=8 Participants
Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm D: Ivermectin ODT 300 µg/kg & Albendazole
n=7 Participants
Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm E: Ivermectin ODT 400 µg/kg & Albendazole
n=7 Participants
Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm F: Ivermectin Standard Tablets & Albendazole
n=9 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
|---|---|---|---|---|---|---|
|
Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR)
|
100.0 percent change in egg counts (%)
Interval 100.0 to 100.0
|
100.0 percent change in egg counts (%)
Interval 100.0 to 100.0
|
100.0 percent change in egg counts (%)
Interval 100.0 to 100.0
|
100.0 percent change in egg counts (%)
Interval 100.0 to 100.0
|
100.0 percent change in egg counts (%)
Interval 100.0 to 100.0
|
100.0 percent change in egg counts (%)
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Subset of participants co-infected with A. lumbricoides at baseline and providing follow-up data.
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 |
Arm A: Ivermectin ODT Placebo & Albendazole
n=10 Participants
Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Ivermectin ODT: Placebo for ivermectin ODT
|
Arm B: Ivermectin ODT 100 µg/kg & Albendazole
n=13 Participants
Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin ODT 200 µg/kg & Albendazole
n=8 Participants
Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm D: Ivermectin ODT 300 µg/kg & Albendazole
n=7 Participants
Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm E: Ivermectin ODT 400 µg/kg & Albendazole
n=7 Participants
Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm F: Ivermectin Standard Tablets & Albendazole
n=9 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
|---|---|---|---|---|---|---|
|
Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR)
|
100.0 percent change in egg counts (%)
Interval 100.0 to 100.0
|
100.0 percent change in egg counts (%)
Interval 100.0 to 100.0
|
100.0 percent change in egg counts (%)
Interval 100.0 to 100.0
|
100.0 percent change in egg counts (%)
Interval 100.0 to 100.0
|
100.0 percent change in egg counts (%)
Interval 100.0 to 100.0
|
100.0 percent change in egg counts (%)
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Subset of participants co-infected with hookworm at baseline and providing follow-up data.
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Outcome measures
| Measure |
Arm A: Ivermectin ODT Placebo & Albendazole
n=8 Participants
Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Ivermectin ODT: Placebo for ivermectin ODT
|
Arm B: Ivermectin ODT 100 µg/kg & Albendazole
n=11 Participants
Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin ODT 200 µg/kg & Albendazole
n=8 Participants
Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm D: Ivermectin ODT 300 µg/kg & Albendazole
n=10 Participants
Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm E: Ivermectin ODT 400 µg/kg & Albendazole
n=7 Participants
Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm F: Ivermectin Standard Tablets & Albendazole
n=7 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
|---|---|---|---|---|---|---|
|
Cure Rate (CR) Against Hookworm
|
100.0 percentage of participants cured (%)
Interval 63.1 to 100.0
|
45.5 percentage of participants cured (%)
Interval 16.8 to 76.6
|
62.5 percentage of participants cured (%)
Interval 24.5 to 91.5
|
70.0 percentage of participants cured (%)
Interval 34.8 to 93.3
|
71.4 percentage of participants cured (%)
Interval 29.0 to 96.3
|
57.1 percentage of participants cured (%)
Interval 18.4 to 90.1
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Subset of participants co-infected with hookworm at baseline and providing follow-up data.
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 |
Arm A: Ivermectin ODT Placebo & Albendazole
n=8 Participants
Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Ivermectin ODT: Placebo for ivermectin ODT
|
Arm B: Ivermectin ODT 100 µg/kg & Albendazole
n=11 Participants
Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin ODT 200 µg/kg & Albendazole
n=8 Participants
Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm D: Ivermectin ODT 300 µg/kg & Albendazole
n=10 Participants
Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm E: Ivermectin ODT 400 µg/kg & Albendazole
n=7 Participants
Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm F: Ivermectin Standard Tablets & Albendazole
n=7 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
|---|---|---|---|---|---|---|
|
Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR)
|
100.0 percent change in egg counts (%)
Interval 100.0 to 100.0
|
93.1 percent change in egg counts (%)
Interval 78.4 to 98.2
|
97.4 percent change in egg counts (%)
Interval 83.0 to 99.8
|
97.9 percent change in egg counts (%)
Interval 92.4 to 100.0
|
98.6 percent change in egg counts (%)
Interval 94.0 to 100.0
|
97.1 percent change in egg counts (%)
Interval 87.4 to 99.7
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Subset of participants co-infected with hookworm at baseline and providing follow-up data.
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 |
Arm A: Ivermectin ODT Placebo & Albendazole
n=8 Participants
Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Ivermectin ODT: Placebo for ivermectin ODT
|
Arm B: Ivermectin ODT 100 µg/kg & Albendazole
n=11 Participants
Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin ODT 200 µg/kg & Albendazole
n=8 Participants
Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm D: Ivermectin ODT 300 µg/kg & Albendazole
n=10 Participants
Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm E: Ivermectin ODT 400 µg/kg & Albendazole
n=7 Participants
Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm F: Ivermectin Standard Tablets & Albendazole
n=7 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
|---|---|---|---|---|---|---|
|
Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR)
|
100.0 percent change in egg counts (%)
Interval 100.0 to 100.0
|
85.7 percent change in egg counts (%)
Interval 54.4 to 93.1
|
88.9 percent change in egg counts (%)
Interval 66.7 to 99.2
|
92.8 percent change in egg counts (%)
Interval 83.6 to 100.0
|
92.2 percent change in egg counts (%)
Interval 82.8 to 100.0
|
62.3 percent change in egg counts (%)
Interval 38.6 to 98.6
|
SECONDARY outcome
Timeframe: 3 hours, 24 hours and 14-21 days post-treatmentPopulation: All participants receiving treatment.
Participants will be monitored at the site for 3 hours following treatment for any acute AEs and reassessment will be done at 24h post-treatment. In addition, participants will be interviewed 3 and 24 hours after treatment and retrospectively at days 14-21 about the occurrence of AEs.
Outcome measures
| Measure |
Arm A: Ivermectin ODT Placebo & Albendazole
n=43 Participants
Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Ivermectin ODT: Placebo for ivermectin ODT
|
Arm B: Ivermectin ODT 100 µg/kg & Albendazole
n=44 Participants
Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin ODT 200 µg/kg & Albendazole
n=42 Participants
Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm D: Ivermectin ODT 300 µg/kg & Albendazole
n=44 Participants
Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm E: Ivermectin ODT 400 µg/kg & Albendazole
n=44 Participants
Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm F: Ivermectin Standard Tablets & Albendazole
n=43 Participants
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs)
3 hours: Abdominal pain
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
3 hours: Diarrhoea
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
3 hours: Vomiting
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
24 hours: Abdominal pain
|
3 participants
|
2 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
24 hours: Diarrhoea
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
4 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
24 hours: Vomiting
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
14-21 days: Abdominal pain
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
14-21 days: Diarrhoea
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
14-21 days: Vomiting
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 24 hours post-treatmentFor characterization of population pharmacokinetics (PK), ivermectin concentration 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 lower limit of quantification of 1-5 ng/ml.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 min post-treatmentTo determine the acceptability of ivermectin ODTs compared to standard tablets, the palatability of each formulation will be rated by children aged 4-5 years using a visual analogue scale with continuous scores from 0 mm (worst taste) to 100 mm (best taste).
Outcome measures
Outcome data not reported
Adverse Events
Arm A: Ivermectin ODT Placebo & Albendazole
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm B: Ivermectin ODT 100 µg/kg & Albendazole
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm C: Ivermectin ODT 200 µg/kg & Albendazole
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm D: Ivermectin ODT 300 µg/kg & Albendazole
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm E: Ivermectin ODT 400 µg/kg & Albendazole
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm F: Ivermectin Standard Tablets & Albendazole
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A: Ivermectin ODT Placebo & Albendazole
n=43 participants at risk
Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Ivermectin ODT: Placebo for ivermectin ODT
|
Arm B: Ivermectin ODT 100 µg/kg & Albendazole
n=44 participants at risk
Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin ODT 200 µg/kg & Albendazole
n=42 participants at risk
Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm D: Ivermectin ODT 300 µg/kg & Albendazole
n=44 participants at risk
Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm E: Ivermectin ODT 400 µg/kg & Albendazole
n=44 participants at risk
Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm F: Ivermectin Standard Tablets & Albendazole
n=43 participants at risk
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
3/43 • Number of events 4 • 2-3 weeks
|
6.8%
3/44 • Number of events 3 • 2-3 weeks
|
2.4%
1/42 • Number of events 1 • 2-3 weeks
|
2.3%
1/44 • Number of events 1 • 2-3 weeks
|
4.5%
2/44 • Number of events 2 • 2-3 weeks
|
2.3%
1/43 • Number of events 1 • 2-3 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/43 • Number of events 1 • 2-3 weeks
|
0.00%
0/44 • 2-3 weeks
|
0.00%
0/42 • 2-3 weeks
|
0.00%
0/44 • 2-3 weeks
|
9.1%
4/44 • Number of events 4 • 2-3 weeks
|
0.00%
0/43 • 2-3 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/43 • 2-3 weeks
|
0.00%
0/44 • 2-3 weeks
|
0.00%
0/42 • 2-3 weeks
|
0.00%
0/44 • 2-3 weeks
|
4.5%
2/44 • Number of events 2 • 2-3 weeks
|
0.00%
0/43 • 2-3 weeks
|
Additional Information
Prof Jennifer Keiser
Swiss Tropical and Public Health Institute
Phone: +41 61 284 82 18
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place