Trial Outcomes & Findings for Efficacy and Safety of MOX/ALB Co-administration (NCT NCT04726969)
NCT ID: NCT04726969
Last Updated: 2024-01-24
Results Overview
The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
255 participants
Primary outcome timeframe
14-21 days after treatment
Results posted on
2024-01-24
Participant Flow
Participant milestones
| Measure |
Arm A: Moxidectin and Albendazole
Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin and 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
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
|
|---|---|---|---|
|
Overall Study
STARTED
|
85
|
84
|
86
|
|
Overall Study
COMPLETED
|
72
|
67
|
71
|
|
Overall Study
NOT COMPLETED
|
13
|
17
|
15
|
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: Moxidectin and Albendazole
n=85 Participants
Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=84 Participants
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin and Albendazole
n=86 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
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
38 Participants
n=85 Participants
|
39 Participants
n=84 Participants
|
33 Participants
n=86 Participants
|
110 Participants
n=255 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=85 Participants
|
45 Participants
n=84 Participants
|
53 Participants
n=86 Participants
|
145 Participants
n=255 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=85 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=255 Participants
|
|
Age, Continuous
|
30.1 years
STANDARD_DEVIATION 16.1 • n=85 Participants
|
26.7 years
STANDARD_DEVIATION 14.5 • n=84 Participants
|
29.9 years
STANDARD_DEVIATION 15.4 • n=86 Participants
|
28.9 years
STANDARD_DEVIATION 15.4 • n=255 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=85 Participants
|
44 Participants
n=84 Participants
|
49 Participants
n=86 Participants
|
137 Participants
n=255 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=85 Participants
|
40 Participants
n=84 Participants
|
37 Participants
n=86 Participants
|
118 Participants
n=255 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Côte D'Ivoire
|
85 Participants
n=85 Participants
|
84 Participants
n=84 Participants
|
86 Participants
n=86 Participants
|
255 Participants
n=255 Participants
|
PRIMARY outcome
Timeframe: 14-21 days after treatmentPopulation: Available case analysis
The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100.
Outcome measures
| Measure |
Arm A: Moxidectin and Albendazole
n=72 Participants
Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=67 Participants
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin and 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
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
|
|---|---|---|---|
|
Cure Rate (CR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura
|
15.3 percentage of participants (%)
Interval 7.9 to 25.7
|
13.4 percentage of participants (%)
Interval 6.3 to 24.0
|
—
|
SECONDARY outcome
Timeframe: 14-21 days after treatmentEggs 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: Moxidectin and Albendazole
n=72 Participants
Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=67 Participants
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin and 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
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
|
|---|---|---|---|
|
Egg Reduction Rate (ERR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura
|
67.0 percent change
Interval 47.8 to 80.1
|
60.2 percent change
Interval 35.7 to 76.5
|
—
|
SECONDARY outcome
Timeframe: 14-21 days after treatmentThe CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100.
Outcome measures
| Measure |
Arm A: Moxidectin and Albendazole
n=67 Participants
Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=71 Participants
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin and 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
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
|
|---|---|---|---|
|
Cure Rate (CR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura
|
13.4 percentage of participants (%)
Interval 6.3 to 24.0
|
22.5 percentage of participants (%)
Interval 13.5 to 34.0
|
—
|
SECONDARY outcome
Timeframe: 14-21 days after treatmentEggs 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: Moxidectin and Albendazole
n=67 Participants
Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=71 Participants
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin and 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
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
|
|---|---|---|---|
|
Egg Reduction Rate (ERR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura
|
60.2 percent change
Interval 35.7 to 76.5
|
81.5 percent change
Interval 68.8 to 89.1
|
—
|
SECONDARY outcome
Timeframe: 14-21 days after treatmentPopulation: Available case analysis
The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100.
Outcome measures
| Measure |
Arm A: Moxidectin and Albendazole
n=22 Participants
Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=22 Participants
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin and Albendazole
n=33 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
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
|
|---|---|---|---|
|
Cure Rates (CRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants
|
95.5 percentage of participants (%)
Interval 86.0 to 100.0
|
95.5 percentage of participants (%)
Interval 86.0 to 100.0
|
100 percentage of participants (%)
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 14-21 days after treatmentPopulation: Available case analysis
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 three treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
Arm A: Moxidectin and Albendazole
n=22 Participants
Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=22 Participants
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin and Albendazole
n=33 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
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
|
|---|---|---|---|
|
Egg Reduction Rates (ERRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants
|
100 percent change
Interval 100.0 to 100.0
|
100 percent change
Interval 100.0 to 100.0
|
100 percent change
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 14-21 days after treatmentPopulation: Available case analysis
The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100.
Outcome measures
| Measure |
Arm A: Moxidectin and Albendazole
n=1 Participants
Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=8 Participants
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin and Albendazole
n=5 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
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
|
|---|---|---|---|
|
Cure Rates (CRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants
|
100 percentage of participants (%)
Interval 100.0 to 100.0
|
37.5 percentage of participants (%)
Interval 0.0 to 80.8
|
20.0 percentage of participants (%)
Interval 0.0 to 75.5
|
SECONDARY outcome
Timeframe: 14-21 days after treatmentPopulation: Available case analysis
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 three treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
Arm A: Moxidectin and Albendazole
n=1 Participants
Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=8 Participants
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin and Albendazole
n=5 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
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
|
|---|---|---|---|
|
Egg Reduction Rates (ERRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants
|
100 percent change
Interval 100.0 to 100.0
|
95.7 percent change
Interval 78.5 to 99.3
|
90.7 percent change
Interval 78.6 to 97.7
|
SECONDARY outcome
Timeframe: 3 hours, 24 hours and 14-21 days after treatmentPopulation: Analysis population at 3 hours after drug administration: N=255 Analysis population at 24 hours after drug administration: N=250 Analysis population at 14-21 days after drug administration: N=210
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: Moxidectin and Albendazole
n=85 Participants
Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=84 Participants
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin and Albendazole
n=86 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
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
|
|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs)
3 hours: Headache
|
1 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
3 hours: Abdominal pain
|
4 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
3 hours: Nausea
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
3 hours: Diarrhea
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
3 hours: Itching
|
1 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
3 hours: Symptoms related to immune system activation
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
24 hours: Headache
|
4 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
24 hours: Abdominal pain
|
8 Participants
|
5 Participants
|
12 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
24 hours: Nausea
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
24 hours: Diarrhea
|
5 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
24 hours: Itching
|
9 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
24 hours: Symptoms related to immune system activation
|
1 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
14-21 days: Headache
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
14-21 days: Abdominal pain
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
14-21 days: Nausea
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
14-21 days: Diarrhea
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
14-21 days: Itching
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
14-21 days: Symptoms related to immune system activation
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 24 hours after treatmentPopulation: Arm B did not receive ivermectin, thus no concentration was measured.
For characterization of population pharmacokinetics (PK) and drug-drug interaction parameters ivermectin, albendazole and its metabolites 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
| Measure |
Arm A: Moxidectin and Albendazole
n=8 Participants
Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=8 Participants
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin and 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
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
|
|---|---|---|---|
|
Concentrations of Albendazole and Ivermectin/Albendazole Combination in Adolescents (Aged 12 to 20 Years)
cmax (albendazole) [ng/ml]
|
26.5 ng/ml
Interval 20.0 to 36.8
|
26.5 ng/ml
Interval 20.0 to 36.8
|
—
|
|
Concentrations of Albendazole and Ivermectin/Albendazole Combination in Adolescents (Aged 12 to 20 Years)
cmax (ivermectin) [ng/ml]
|
—
|
40.1 ng/ml
Interval 32.4 to 59.1
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: before treatment, i.e. at enrolmentPopulation: This analysis has not been performed.
In case of unexpected results for outcome measure 10 (Concentrations of Albendazole and Ivermectin/Albendazole Combination in Adolescents (Aged 12 to 20 Years)), whole genome sequencing will be performed on blood samples from participants in the ivermectin/albendazole arm to analyse genetic variation of relevance for ivermectin metabolism.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: before treatment, i.e. at screening, and 14-21 days after treatmentTaxonomic relative abundances of gut bacterial communities will be analysed with high-throughput sequencing. Absolute abundances of specific taxa will be measured using taxon-specific qPCR. Changes in relative and absolute abundances will be measured before and after treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: before treatment, i.e. at enrolmentBlood type of participants will be collected during clinical examination prior treatment using blood type determination cards.
Outcome measures
| Measure |
Arm A: Moxidectin and Albendazole
n=85 Participants
Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=84 Participants
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin and Albendazole
n=86 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
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
|
|---|---|---|---|
|
Exploratory Outcome: Number of Participants Within Each Blood Type Category (A, B, AB and 0)
Blood type 0
|
48 Participants
|
47 Participants
|
47 Participants
|
|
Exploratory Outcome: Number of Participants Within Each Blood Type Category (A, B, AB and 0)
Blood type A
|
20 Participants
|
18 Participants
|
12 Participants
|
|
Exploratory Outcome: Number of Participants Within Each Blood Type Category (A, B, AB and 0)
Blood type B
|
15 Participants
|
16 Participants
|
24 Participants
|
|
Exploratory Outcome: Number of Participants Within Each Blood Type Category (A, B, AB and 0)
Blood type AB
|
2 Participants
|
3 Participants
|
3 Participants
|
Adverse Events
Arm A: Moxidectin and Albendazole
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Arm B: Albendazole
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Arm C: Ivermectin and Albendazole
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A: Moxidectin and Albendazole
n=85 participants at risk
Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=84 participants at risk
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm C: Ivermectin and Albendazole
n=86 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
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin
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|---|---|---|---|
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General disorders
Headache
|
4.7%
4/85 • Number of events 5 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
14.3%
12/84 • Number of events 14 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
14.0%
12/86 • Number of events 13 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.9%
11/85 • Number of events 12 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
11.9%
10/84 • Number of events 11 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
20.9%
18/86 • Number of events 20 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
|
General disorders
Nausea
|
4.7%
4/85 • Number of events 4 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
2.4%
2/84 • Number of events 2 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
5.8%
5/86 • Number of events 5 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
6/85 • Number of events 7 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
4.8%
4/84 • Number of events 5 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
8.1%
7/86 • Number of events 8 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
|
Skin and subcutaneous tissue disorders
Itching
|
10.6%
9/85 • Number of events 10 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
13.1%
11/84 • Number of events 14 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
5.8%
5/86 • Number of events 6 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
|
General disorders
Allergic reaction
|
2.4%
2/85 • Number of events 2 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
0.00%
0/84 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
2.3%
2/86 • Number of events 2 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
|
Immune system disorders
Symptoms related to immune system activation
|
4.7%
4/85 • Number of events 4 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
11.9%
10/84 • Number of events 10 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
|
9.3%
8/86 • Number of events 8 • 14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours 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.
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Additional Information
Prof Dr 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