Trial · NCT04848688
Efficacy and Safety of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis
NCT04848688, Phase 3, Completed, Jennifer Keiser; results first posted 2024-01-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis. Trials, record NCT04848688. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04848688
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis
- NCT number
- NCT04848688
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 332 participants, actual
- Lead sponsor
- Jennifer Keiser
- Conditions
- Strongyloides Stercoralis Infection
- Interventions
- Moxidectin 2 mg, Ivermectin 3 mg, Placebo
- First posted
- 2021-04-19
- Last updated
- 2024-01-25
- Results first posted
- 2024-01-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cure Rate Against Strongyloides Stercoralis | 14-21 days after treatment | The conversion from being larvae positive pre-treatment to larvae negative post-treatment, or cure rate (CR). |
| Secondary | Larvae Reduction Rate (LRR) Against Strongyloidiasis Stercoralis | 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) |
| Secondary | CRs Against Concomitant Soil-transmitted Helminth Infections - Ascaris Lumbricoides | 14-21 days after treatment | CRs will be calculated for Ascaris lumbricoides, Trichuris trichiura and hookworm infections as described in primary outcome. |
| Secondary | CRs Against Concomitant Soil-transmitted Helminth Infections - Trichuris Trichiura | 14-21 days after treatment | CRs will be calculated for Ascaris lumbricoides, Trichuris trichiura and hookworm infections as described in primary outcome. |
| Secondary | CRs Against Concomitant Soil-transmitted Helminth Infections - Hookworm | 14-21 days after treatment | CRs will be calculated for Ascaris lumbricoides, Trichuris trichiura and hookworm infections as described in primary outcome. |
| Secondary | Number of Participants Reporting Adverse Events | 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. | 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. |
| Other | Socioeconomic Characteristics (SES) | Pre-treatment | To all participating households, a brief questionnaire will be administered assessing information on socioeconomic characteristics (SES) and access to sanitation, water facilities, and hygiene behaviour. |
| Other | Genetic Profiling of S. Stercoralis Positive Stool Samples | Pre-treatment | From 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cure Rate Against Strongyloides Stercoralis | 14-21 days after treatment | percentage of participants | NUMBER | |
| SECONDARY | Larvae Reduction Rate (LRR) Against Strongyloidiasis Stercoralis | 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. | percent change | GEOMETRIC_MEAN | |
| SECONDARY | CRs Against Concomitant Soil-transmitted Helminth Infections - Ascaris Lumbricoides | 14-21 days after treatment | No participants infected with Ascaris lumbricoides pre- or post-treatment | ||
| SECONDARY | CRs Against Concomitant Soil-transmitted Helminth Infections - Trichuris Trichiura | 14-21 days after treatment | No participants infected with Trichuris trichiura pre- or post-treatment | ||
| SECONDARY | CRs Against Concomitant Soil-transmitted Helminth Infections - Hookworm | 14-21 days after treatment | Participants co-infected with Hookworm | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Reporting Adverse Events | 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. | 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 | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Socioeconomic Characteristics (SES) | Pre-treatment | |||
| OTHER_PRE_SPECIFIED | Genetic Profiling of S. Stercoralis Positive Stool Samples | Pre-treatment |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cure Rate Against Strongyloides Stercoralis | Moxidectin | 94.8 | 95% Confidence Interval 90.0 to 97.7 | percentage of participants | |
| Cure Rate Against Strongyloides Stercoralis | Ivermectin | 99.4 | 95% Confidence Interval 96.6 to 100 | percentage of participants | |
| Larvae Reduction Rate (LRR) Against Strongyloidiasis Stercoralis | Moxidectin | 98.8 | 95% Confidence Interval 96.0 to 99.9 | percent change | |
| Larvae Reduction Rate (LRR) Against Strongyloidiasis Stercoralis | Ivermectin | 100 | 95% Confidence Interval 100 to 100 | percent change | |
| CRs Against Concomitant Soil-transmitted Helminth Infections - Hookworm | Moxidectin | 82.0 | 95% Confidence Interval 74.7 to 89.2 | percentage of participants | |
| CRs Against Concomitant Soil-transmitted Helminth Infections - Hookworm | Ivermectin | 81.0 | 95% Confidence Interval 73.2 to 88.8 | percentage of participants | |
| Number of Participants Reporting Adverse Events | Moxidectin | 2-3 hours: Headache | 4 | Participants | |
| Number of Participants Reporting Adverse Events | Ivermectin | 2-3 hours: Headache | 10 | Participants | |
| Number of Participants Reporting Adverse Events | Moxidectin | 2-3 hours: Abdominal pain | 2 | Participants | |
| Number of Participants Reporting Adverse Events | Ivermectin | 2-3 hours: Abdominal pain | 4 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Moxidectin | 166 | |
| Overall Study | STARTED | Ivermectin | 166 | |
| Overall Study | COMPLETED | Moxidectin | 154 | |
| Overall Study | COMPLETED | Ivermectin | 161 | |
| Overall Study | NOT COMPLETED | Moxidectin | 12 | |
| Overall Study | NOT COMPLETED | Ivermectin | 5 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Moxidectin | 3 | 166 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Ivermectin | 5 | 166 | 5 |
| other | Diarrhea | Gastrointestinal disorders | Moxidectin | 1 | 166 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Ivermectin | 2 | 166 | 2 |
| other | Vomiting | Gastrointestinal disorders | Moxidectin | 0 | 166 | 0 |
| other | Vomiting | Gastrointestinal disorders | Ivermectin | 1 | 166 | 1 |
| other | Allergic reaction | General disorders | Moxidectin | 0 | 166 | 0 |
| other | Allergic reaction | General disorders | Ivermectin | 0 | 166 | 0 |
| other | Headache | General disorders | Moxidectin | 8 | 166 | 8 |
| other | Headache | General disorders | Ivermectin | 10 | 166 | 12 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Moxidectin | 0 | 166 |
| Total, all-cause mortality | Ivermectin | 0 | 166 |
| Total, other adverse events | Moxidectin | 15 | 166 |
| Total, other adverse events | Ivermectin | 19 | 166 |
| Total, serious adverse events | Moxidectin | 0 | 166 |
| Total, serious adverse events | Ivermectin | 0 | 166 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37949090 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Moxidectin vs Ivermectin: deaths from any cause | Trial comparisons |
| Moxidectin vs Ivermectin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04848688
GET https://conductscience.org/api/trials/v1/NCT04848688/results?page=2