Trial Outcomes & Findings for Efficacy and Safety of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis (NCT NCT04848688)
NCT ID: NCT04848688
Last Updated: 2024-01-25
Results Overview
The conversion from being larvae positive pre-treatment to larvae negative post-treatment, or cure rate (CR).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
332 participants
Primary outcome timeframe
14-21 days after treatment
Results posted on
2024-01-25
Participant Flow
Participant milestones
| Measure |
Moxidectin
8 mg Moxidectin at day 0 administered orally
Moxidectin 2 mg: Monotherapy, oral administration, single-dose, fixed-dose, 4 tablets of 2 mg each to yield an 8 mg final dose.
Placebo: Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
|
Ivermectin
200 ug/kg Ivermectin at day 0 administered orally
Ivermectin 3 mg: Monotherapy, oral administration, single-dose, weight dependent, The number of tablets will be adjusted according to the patients' weight to yield 200 ug/kg final dose.
Placebo: Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
166
|
|
Overall Study
COMPLETED
|
154
|
161
|
|
Overall Study
NOT COMPLETED
|
12
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Moxidectin
n=166 Participants
8 mg Moxidectin at day 0 administered orally
Moxidectin 2 mg: Monotherapy, oral administration, single-dose, fixed-dose, 4 tablets of 2 mg each to yield an 8 mg final dose.
Placebo: Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
|
Ivermectin
n=166 Participants
200 ug/kg Ivermectin at day 0 administered orally
Ivermectin 3 mg: Monotherapy, oral administration, single-dose, weight dependent, The number of tablets will be adjusted according to the patients' weight to yield 200 ug/kg final dose.
Placebo: Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
|
Total
n=332 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 12.8 • n=166 Participants
|
45.0 years
STANDARD_DEVIATION 12.7 • n=166 Participants
|
44.9 years
STANDARD_DEVIATION 12.8 • n=332 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=166 Participants
|
86 Participants
n=166 Participants
|
165 Participants
n=332 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=166 Participants
|
80 Participants
n=166 Participants
|
167 Participants
n=332 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Cambodia
|
166 participants
n=166 Participants
|
166 participants
n=166 Participants
|
332 participants
n=332 Participants
|
|
Strongyloides stercoralis infection intensity
Light
|
102 Participants
n=166 Participants
|
103 Participants
n=166 Participants
|
205 Participants
n=332 Participants
|
|
Strongyloides stercoralis infection intensity
Moderate
|
44 Participants
n=166 Participants
|
44 Participants
n=166 Participants
|
88 Participants
n=332 Participants
|
|
Strongyloides stercoralis infection intensity
Heavy
|
20 Participants
n=166 Participants
|
19 Participants
n=166 Participants
|
39 Participants
n=332 Participants
|
PRIMARY outcome
Timeframe: 14-21 days after treatmentThe conversion from being larvae positive pre-treatment to larvae negative post-treatment, or cure rate (CR).
Outcome measures
| Measure |
Moxidectin
n=154 Participants
8 mg Moxidectin at day 0 administered orally
Moxidectin 2 mg: Monotherapy, oral administration, single-dose, fixed-dose, 4 tablets of 2 mg each to yield an 8 mg final dose.
Placebo: Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
|
Ivermectin
n=161 Participants
200 ug/kg Ivermectin at day 0 administered orally
Ivermectin 3 mg: Monotherapy, oral administration, single-dose, weight dependent, The number of tablets will be adjusted according to the patients' weight to yield 200 ug/kg final dose.
Placebo: Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
|
|---|---|---|
|
Cure Rate Against Strongyloides Stercoralis
|
94.8 percentage of participants
Interval 90.0 to 97.7
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
SECONDARY outcome
Timeframe: 14-21 days after treatment. The originally planned follow-ups at 42-49 days and 63-70 days as well as the sample collection every second day between day 0 and day 70 (Moxidectin arm, n=50) was not performed.Larvae per gram (LPG) stool sample will be assessed by calculating the mean of the larvae counts from the three duplicate Baermann assays and divided by the mean weighted amount of these stool samples. The LRR will be calculated following: (LRR = (1-(mean at follow-up/mean at baseline))\*100)
Outcome measures
| Measure |
Moxidectin
n=154 Participants
8 mg Moxidectin at day 0 administered orally
Moxidectin 2 mg: Monotherapy, oral administration, single-dose, fixed-dose, 4 tablets of 2 mg each to yield an 8 mg final dose.
Placebo: Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
|
Ivermectin
n=161 Participants
200 ug/kg Ivermectin at day 0 administered orally
Ivermectin 3 mg: Monotherapy, oral administration, single-dose, weight dependent, The number of tablets will be adjusted according to the patients' weight to yield 200 ug/kg final dose.
Placebo: Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
|
|---|---|---|
|
Larvae Reduction Rate (LRR) Against Strongyloidiasis Stercoralis
|
98.8 percent change
Interval 96.0 to 99.9
|
100 percent change
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 14-21 days after treatmentPopulation: No participants infected with Ascaris lumbricoides pre- or post-treatment
CRs will be calculated for Ascaris lumbricoides, Trichuris trichiura and hookworm infections as described in primary outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14-21 days after treatmentPopulation: No participants infected with Trichuris trichiura pre- or post-treatment
CRs will be calculated for Ascaris lumbricoides, Trichuris trichiura and hookworm infections as described in primary outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14-21 days after treatmentPopulation: Participants co-infected with Hookworm
CRs will be calculated for Ascaris lumbricoides, Trichuris trichiura and hookworm infections as described in primary outcome.
Outcome measures
| Measure |
Moxidectin
n=111 Participants
8 mg Moxidectin at day 0 administered orally
Moxidectin 2 mg: Monotherapy, oral administration, single-dose, fixed-dose, 4 tablets of 2 mg each to yield an 8 mg final dose.
Placebo: Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
|
Ivermectin
n=100 Participants
200 ug/kg Ivermectin at day 0 administered orally
Ivermectin 3 mg: Monotherapy, oral administration, single-dose, weight dependent, The number of tablets will be adjusted according to the patients' weight to yield 200 ug/kg final dose.
Placebo: Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
|
|---|---|---|
|
CRs Against Concomitant Soil-transmitted Helminth Infections - Hookworm
|
82.0 percentage of participants
Interval 74.7 to 89.2
|
81.0 percentage of participants
Interval 73.2 to 88.8
|
SECONDARY outcome
Timeframe: 2-3 hours, 24 hours and 14-21 days after treatment. The originally planned follow-ups at 42-49 days and 63-70 days after treatment were not conducted.Population: Analysis population at 2-3 hours after drug administration: N=332. Analysis population at 24 hours after drug administration: N=332. Analysis population at 14-21 days after drug administration: N=315.
Participants will be monitored on site for at least 3 hours following treatment for any acute adverse events. In addition, participants will be interviewed 2-3 and 24 hours and at several weeks after treatment about the occurrence of adverse events. A standardized symptom questionnaire is used, that includes the recording of headache, abdominal pain, itching, nausea, vomiting, diarrhea, allergic reaction as well as any further mentioned event by the participant.
Outcome measures
| Measure |
Moxidectin
n=166 Participants
8 mg Moxidectin at day 0 administered orally
Moxidectin 2 mg: Monotherapy, oral administration, single-dose, fixed-dose, 4 tablets of 2 mg each to yield an 8 mg final dose.
Placebo: Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
|
Ivermectin
n=166 Participants
200 ug/kg Ivermectin at day 0 administered orally
Ivermectin 3 mg: Monotherapy, oral administration, single-dose, weight dependent, The number of tablets will be adjusted according to the patients' weight to yield 200 ug/kg final dose.
Placebo: Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
|
|---|---|---|
|
Number of Participants Reporting Adverse Events
2-3 hours: Vomiting
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
2-3 hours: Headache
|
4 Participants
|
10 Participants
|
|
Number of Participants Reporting Adverse Events
2-3 hours: Itching
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
2-3 hours: Nausea
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
2-3 hours: Diarrhea
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Adverse Events
2-3 hours: Allergic reaction
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
24 hours: Headache
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting Adverse Events
24 hours: Abdominal pain
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Adverse Events
24 hours: Itching
|
2 Participants
|
5 Participants
|
|
Number of Participants Reporting Adverse Events
24 hours: Nausea
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
24 hours: Diarrhea
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Adverse Events
24 hours: Allergic reaction
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
14-21 days: Headache
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
14-21 days: Abdominal pain
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
14-21 days: Itching
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
14-21 days: Nausea
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
14-21 days: Vomiting
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
14-21 days: Diarrhea
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
14-21 days: Allergic reaction
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
2-3 hours: Abdominal pain
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Adverse Events
24 hours: Vomiting
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatmentTo all participating households, a brief questionnaire will be administered assessing information on socioeconomic characteristics (SES) and access to sanitation, water facilities, and hygiene behaviour.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatmentFrom all S. stercoralis positive stool samples, the extracted larvae will be stored in 70% Ethanol after examination by Baermann. Samples will be shipped to the investigating laboratory (La Trobe University) at room temperature.
Outcome measures
Outcome data not reported
Adverse Events
Moxidectin
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Ivermectin
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Moxidectin
n=166 participants at risk
8 mg Moxidectin at day 0 administered orally
Moxidectin 2 mg: Monotherapy, oral administration, single-dose, fixed-dose, 4 tablets of 2 mg each to yield an 8 mg final dose.
Placebo: Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
|
Ivermectin
n=166 participants at risk
200 ug/kg Ivermectin at day 0 administered orally
Ivermectin 3 mg: Monotherapy, oral administration, single-dose, weight dependent, The number of tablets will be adjusted according to the patients' weight to yield 200 ug/kg final dose.
Placebo: Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
3/166 • Number of events 3 • 14-21 days
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 14-21 days about the occurrence of adverse events. Since no adverse events were reported at 14-21 days post-treatment, the adverse events table contains the summary of events reported within 24 hours after drug administration.
|
3.0%
5/166 • Number of events 5 • 14-21 days
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 14-21 days about the occurrence of adverse events. Since no adverse events were reported at 14-21 days post-treatment, the adverse events table contains the summary of events reported within 24 hours after drug administration.
|
|
Gastrointestinal disorders
Diarrhea
|
0.60%
1/166 • Number of events 1 • 14-21 days
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 14-21 days about the occurrence of adverse events. Since no adverse events were reported at 14-21 days post-treatment, the adverse events table contains the summary of events reported within 24 hours after drug administration.
|
1.2%
2/166 • Number of events 2 • 14-21 days
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 14-21 days about the occurrence of adverse events. Since no adverse events were reported at 14-21 days post-treatment, the adverse events table contains the summary of events reported within 24 hours after drug administration.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/166 • 14-21 days
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 14-21 days about the occurrence of adverse events. Since no adverse events were reported at 14-21 days post-treatment, the adverse events table contains the summary of events reported within 24 hours after drug administration.
|
0.60%
1/166 • Number of events 1 • 14-21 days
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 14-21 days about the occurrence of adverse events. Since no adverse events were reported at 14-21 days post-treatment, the adverse events table contains the summary of events reported within 24 hours after drug administration.
|
|
General disorders
Allergic reaction
|
0.00%
0/166 • 14-21 days
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 14-21 days about the occurrence of adverse events. Since no adverse events were reported at 14-21 days post-treatment, the adverse events table contains the summary of events reported within 24 hours after drug administration.
|
0.00%
0/166 • 14-21 days
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 14-21 days about the occurrence of adverse events. Since no adverse events were reported at 14-21 days post-treatment, the adverse events table contains the summary of events reported within 24 hours after drug administration.
|
|
General disorders
Headache
|
4.8%
8/166 • Number of events 8 • 14-21 days
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 14-21 days about the occurrence of adverse events. Since no adverse events were reported at 14-21 days post-treatment, the adverse events table contains the summary of events reported within 24 hours after drug administration.
|
6.0%
10/166 • Number of events 12 • 14-21 days
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 14-21 days about the occurrence of adverse events. Since no adverse events were reported at 14-21 days post-treatment, the adverse events table contains the summary of events reported within 24 hours after drug administration.
|
|
General disorders
Nausea
|
0.00%
0/166 • 14-21 days
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 14-21 days about the occurrence of adverse events. Since no adverse events were reported at 14-21 days post-treatment, the adverse events table contains the summary of events reported within 24 hours after drug administration.
|
0.00%
0/166 • 14-21 days
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 14-21 days about the occurrence of adverse events. Since no adverse events were reported at 14-21 days post-treatment, the adverse events table contains the summary of events reported within 24 hours after drug administration.
|
|
Skin and subcutaneous tissue disorders
Itching
|
2.4%
4/166 • Number of events 5 • 14-21 days
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 14-21 days about the occurrence of adverse events. Since no adverse events were reported at 14-21 days post-treatment, the adverse events table contains the summary of events reported within 24 hours after drug administration.
|
3.0%
5/166 • Number of events 5 • 14-21 days
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 14-21 days about the occurrence of adverse events. Since no adverse events were reported at 14-21 days post-treatment, the adverse events table contains the summary of events reported within 24 hours after drug administration.
|
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