Trial Outcomes & Findings for Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients (NCT NCT04041453)
NCT ID: NCT04041453
Last Updated: 2020-07-29
Results Overview
Number of individuals cured from Trichuris trichiura infection using the duplicate Kato Katz laboratory method on a single sample of fresh stools as the measurement tool. Cure rate is defined as the absence of Trichuris trichiura eggs in post-treatment samples.
COMPLETED
PHASE2
176 participants
21 days
2020-07-29
Participant Flow
Participant milestones
| Measure |
Albendazole 400mg
Albendazole 400mg in single dose
|
Albendazole/Ivermectin
Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose.
|
Albendazole 400mg x 3
Albendazole 400mg/day for 3 consecutive days.
|
Albendazole/Ivermectin x 3
Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
38
|
57
|
23
|
58
|
|
Overall Study
Safety Population
|
38
|
56
|
23
|
58
|
|
Overall Study
COMPLETED
|
24
|
35
|
18
|
40
|
|
Overall Study
NOT COMPLETED
|
14
|
22
|
5
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Albendazole 400mg
n=38 Participants
Albendazole 400mg in single dose
|
Albendazole/Ivermectin
n=57 Participants
Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose.
|
Albendazole 400mg x 3
n=23 Participants
Albendazole 400mg/day for 3 consecutive days
|
Albendazole/Ivermectin x 3
n=58 Participants
Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.5 years
STANDARD_DEVIATION 2.6 • n=38 Participants
|
8.0 years
STANDARD_DEVIATION 2.2 • n=57 Participants
|
8.5 years
STANDARD_DEVIATION 2.0 • n=23 Participants
|
8.0 years
STANDARD_DEVIATION 2.2 • n=58 Participants
|
8.2 years
STANDARD_DEVIATION 2.3 • n=176 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=38 Participants
|
24 Participants
n=57 Participants
|
13 Participants
n=23 Participants
|
30 Participants
n=58 Participants
|
86 Participants
n=176 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=38 Participants
|
33 Participants
n=57 Participants
|
10 Participants
n=23 Participants
|
28 Participants
n=58 Participants
|
90 Participants
n=176 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 21 daysPopulation: The follow-up visit for efficacy assessment on Day 21 post-drug administration was not conducted in 52 subjects due to the outbreak of COVID-19 pandemic in Honduras which precluded completion of study visits in March 2020. Additional 7 subjects did not complete the study: 1 did not take the study medication, and 6 subjects were lost to follow up.
Number of individuals cured from Trichuris trichiura infection using the duplicate Kato Katz laboratory method on a single sample of fresh stools as the measurement tool. Cure rate is defined as the absence of Trichuris trichiura eggs in post-treatment samples.
Outcome measures
| Measure |
Albendazole 400mg
n=24 Participants
Albendazole 400mg in single dose
|
Albendazole/Ivermectin
n=35 Participants
Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose.
|
Albendazole 400mg x3
n=18 Participants
Albendazole 400mg/day for 3 consecutive days.
|
Albendazole/Ivermectin x 3
n=40 Participants
Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days
|
|---|---|---|---|---|
|
Cure Rate
|
1 Participants
|
31 Participants
|
6 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 21 daysPopulation: The follow-up visit for efficacy assessment on Day 21 post-drug administration was not conducted in 52 subjects due to the outbreak of COVID-19 pandemic in Honduras which precluded completion of study visits in March 2020. Additional 7 subjects did not complete the study: 1 did not take the study medication, and 6 subjects were lost to follow up.
Calculation details: 100 x (1 - arithmetic mean fecal egg count post-intervention / arithmetic mean fecal egg count pre-intervention) Egg change rate was calculated across all participants, as described in reference: Levecke B et al., PLoS Negl Trop Dis. 2014;8(10).
Outcome measures
| Measure |
Albendazole 400mg
n=24 Participants
Albendazole 400mg in single dose
|
Albendazole/Ivermectin
n=35 Participants
Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose.
|
Albendazole 400mg x3
n=18 Participants
Albendazole 400mg/day for 3 consecutive days.
|
Albendazole/Ivermectin x 3
n=40 Participants
Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days
|
|---|---|---|---|---|
|
Egg Change Rate
|
50 Percent change
|
97 Percent change
|
72 Percent change
|
100 Percent change
|
SECONDARY outcome
Timeframe: 21daysMeasurement of the incidence of mutations of tubulin in Trichuris trichiura eggs collected pre and post treatment using molecular biology techniques. This data is not available yet due to the COVID-19 pandemic, but the data will be available and reported in the future. Anticipated reporting date for this outcome measure is estimated by 2021 and will be confirmed once the pandemic is over.
Outcome measures
Outcome data not reported
Adverse Events
Albendazole 400mg
Albendazole/Ivermectin
Albendazole 400mg x3
Albendazole/Ivermectin x 3
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Albendazole 400mg
n=38 participants at risk
Albendazole 400mg in single dose
|
Albendazole/Ivermectin
n=56 participants at risk
Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose
|
Albendazole 400mg x3
n=23 participants at risk
Albendazole 400mg/day in 3 consecutive days
|
Albendazole/Ivermectin x 3
n=58 participants at risk
Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day in 3 consecutive days
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/38 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
7.1%
4/56 • Number of events 4 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
8.7%
2/23 • Number of events 2 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
6.9%
4/58 • Number of events 4 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/38 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
0.00%
0/56 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
0.00%
0/23 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
1.7%
1/58 • Number of events 1 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/38 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
0.00%
0/56 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
4.3%
1/23 • Number of events 1 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
1.7%
1/58 • Number of events 1 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
|
Eye disorders
Photophobia
|
0.00%
0/38 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
0.00%
0/56 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
8.7%
2/23 • Number of events 2 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
0.00%
0/58 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
|
General disorders
Headache
|
0.00%
0/38 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
8.9%
5/56 • Number of events 5 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
8.7%
2/23 • Number of events 2 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
6.9%
4/58 • Number of events 4 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/38 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
1.8%
1/56 • Number of events 1 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
0.00%
0/23 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
0.00%
0/58 • Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
|
Additional Information
Alejandro J Krolewiecki
Universidad Nacional de Salta
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place