Trial · NCT04700423
Efficacy and Safety of MOX/ALB vs. IVM/ALB Co-administration
NCT04700423, Phase 2, Phase 3, Completed, Jennifer Keiser; results first posted 2024-12-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of MOX/ALB vs. IVM/ALB Co-administration. Trials, record NCT04700423. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04700423
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of MOX/ALB vs. IVM/ALB Co-administration
- NCT number
- NCT04700423
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 536 participants, actual
- Lead sponsor
- Jennifer Keiser
- Conditions
- Trichuriasis, Ascariasis, Hookworm Infections, Helminthes; Infestation, Intestinal
- Interventions
- moxidectin (8 mg) / albendazole (400 mg), ivermectin (200 µg/kg) / albendazole (400 mg), ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL], ivermectin (200 µg/kg), moxidectin (8 mg)
- First posted
- 2021-01-07
- Last updated
- 2024-12-05
- Results first posted
- 2024-12-05
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Egg Reduction Rate Against T. Trichiura | 14-21 day post-treatment | Egg reduction rate is calculated as the relative reduction in the group geometric mean egg output after co-administration of moxidectin/ albendazole and ivermectin/ albendazole assessed at 14-21 days post-treatment compared to the baseline levels. |
| Secondary | Number of Participants With Adverse Events | 3 hours, 24 hours, 14-21 days, 5-6 weeks and 3 months post-treatment | The observation time for AE starts when the treatment is initiated. Subjects will be kept for observation for at least 3 hours following treatment for any acute AE and. If there is any abnormal finding, the local study physician will perform a full clinical examination and findings will be recorded. An emergency kit will be available on site to treat any medical conditions that warrant urgent medical intervention. Participants will also be interviewed at 3h and 24h as well as retrospectively 14 -21 days, 5-6 weeks and 3 months after treatment about the occurrence of AEs. |
| Secondary | Superiority in Terms of Cure Rates (CRs) | 14-21 day post-treatment | Assessment of superiority in terms of CRs of the drug combinations compared to their corresponding monotherapies: Arm C: Albendazole (400 mg) Arm D: Ivermectin (200 μg/kg) and Arm E: Moxidectin (8 mg). Cure rates is defined as the percentages of participants treated with Moxidectin (8 mg)/Albendazole (400 mg), Ivermectin (200 μg/kg)/Albendazole (400 mg), Albendazole (400 mg), Ivermectin (200 μg/kg) or Moxidectin (8 mg) who were cured of infections with T. trichiura. |
| Secondary | Cure Rates Against T. Trichiura | 14-21 day post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Secondary | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 5-6 weeks post-treatment | Eggs per gram of stool 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. |
| Secondary | Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 5-6 weeks post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Secondary | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 3 Months | 3 months post-treatment | Eggs per gram of stool 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. |
| Secondary | Extended Effects (Cure Rates) on Follow-up of T. Trichiura: 3 Months | 3 months post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Secondary | Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 14-21 days post-treatment | Eggs per gram of stool 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. |
| Secondary | Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 14-21 days post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Egg Reduction Rate Against T. Trichiura | 14-21 day post-treatment | Geometric mean reduction in number of eggs at baseline and assessed at 14-21 days post-treatment | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Adverse Events | 3 hours, 24 hours, 14-21 days, 5-6 weeks and 3 months post-treatment | number analyzed corresponds to the number of participants assessed per time point | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Superiority in Terms of Cure Rates (CRs) | 14-21 day post-treatment | Percentage of participants | NUMBER | |
| SECONDARY | Cure Rates Against T. Trichiura | 14-21 day post-treatment | Number of participants found positive for hookworm at 14-21 days post-treatment | Percentage of participants | NUMBER |
| SECONDARY | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 5-6 weeks post-treatment | Geometric mean reduction in number of eggs at baseline and assessed at 5-6 weeks post-treatment | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 5-6 weeks post-treatment | Number of participants found positive for hookworm at 5-6 weeks post-treatment | Percentage of participants | NUMBER |
| SECONDARY | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 3 Months | 3 months post-treatment | Geometric mean reduction in number of eggs at baseline and assessed at 3 months post-treatment | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Extended Effects (Cure Rates) on Follow-up of T. Trichiura: 3 Months | 3 months post-treatment | Number of participants found positive for T. trichiura at baseline and assessed at 3 months post-treatment | Percentage of participants | NUMBER |
| SECONDARY | Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 14-21 days post-treatment | Geometric mean reduction in number of eggs at baseline and assessed at 14-21 days post-treatment | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 14-21 days post-treatment | Number of participants found positive for hookworm at baseline and assessed at 14-21 days post-treatment | Percentage of participants | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group125
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Egg Reduction Rate Against T. Trichiura | A: Moxidectin (8 mg) / Albendazole (400 mg) | 96.8 | 95% Confidence Interval 95.8 to 97.6 | Percent change | |
| Egg Reduction Rate Against T. Trichiura | B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | 99.0 | 95% Confidence Interval 98.7 to 99.3 | Percent change | |
| Egg Reduction Rate Against T. Trichiura | C: Albendazole (400 mg) | 86.2 | 95% Confidence Interval 61.8 to 95.6 | Percent change | |
| Egg Reduction Rate Against T. Trichiura | D: Ivermectin (200 µg/kg) | 94.2 | 95% Confidence Interval 89.3 to 97.1 | Percent change | |
| Egg Reduction Rate Against T. Trichiura | E: Moxidectin (8 mg) | 85.5 | 95% Confidence Interval 79.7 to 89.8 | Percent change | |
| Number of Participants With Adverse Events | A: Moxidectin (8 mg) / Albendazole (400 mg) | Baseline | 7 | Participants | |
| Number of Participants With Adverse Events | B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Baseline | 9 | Participants | |
| Number of Participants With Adverse Events | C: Albendazole (400 mg) | Baseline | 0 | Participants | |
| Number of Participants With Adverse Events | D: Ivermectin (200 µg/kg) | Baseline | 0 | Participants | |
| Number of Participants With Adverse Events | E: Moxidectin (8 mg) | Baseline | 0 | Participants |
1 to 10 of 125Source ClinicalTrials.gov
See all 125 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline/Treatment | STARTED | A: Moxidectin (8 mg) / Albendazole (400 mg) | 207 | |
| Baseline/Treatment | STARTED | B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | 211 | |
| Baseline/Treatment | STARTED | C: Albendazole (400 mg) | 19 | |
| Baseline/Treatment | STARTED | D: Ivermectin (200 µg/kg) | 19 | |
| Baseline/Treatment | STARTED | E: Moxidectin (8 mg) | 80 | |
| Baseline/Treatment | COMPLETED | A: Moxidectin (8 mg) / Albendazole (400 mg) | 207 | |
| Baseline/Treatment | COMPLETED | B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | 211 | |
| Baseline/Treatment | COMPLETED | C: Albendazole (400 mg) | 19 | |
| Baseline/Treatment | COMPLETED | D: Ivermectin (200 µg/kg) | 19 | |
| Baseline/Treatment | COMPLETED | E: Moxidectin (8 mg) | 80 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events65
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 | Headache | General disorders | A: Moxidectin (8 mg) / Albendazole (400 mg) | 30 | 207 | |
| other | Headache | General disorders | B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | 38 | 211 | |
| other | Headache | General disorders | C: Albendazole (400 mg) | 3 | 19 | |
| other | Headache | General disorders | D: Ivermectin (200 µg/kg) | 2 | 19 | |
| other | Headache | General disorders | E: Moxidectin (8 mg) | 6 | 80 | |
| other | Abdominal pain | General disorders | A: Moxidectin (8 mg) / Albendazole (400 mg) | 13 | 207 | |
| other | Abdominal pain | General disorders | B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | 16 | 211 | |
| other | Abdominal pain | General disorders | C: Albendazole (400 mg) | 1 | 19 | |
| other | Abdominal pain | General disorders | D: Ivermectin (200 µg/kg) | 1 | 19 | |
| other | Abdominal pain | General disorders | E: Moxidectin (8 mg) | 4 | 80 |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A: Moxidectin (8 mg) / Albendazole (400 mg) | 0 | 207 |
| Total, all-cause mortality | B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | 0 | 211 |
| Total, all-cause mortality | C: Albendazole (400 mg) | 0 | 19 |
| Total, all-cause mortality | D: Ivermectin (200 µg/kg) | 0 | 19 |
| Total, all-cause mortality | E: Moxidectin (8 mg) | 0 | 80 |
| Total, other adverse events | A: Moxidectin (8 mg) / Albendazole (400 mg) | 73 | 207 |
| Total, other adverse events | B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | 93 | 211 |
| Total, other adverse events | C: Albendazole (400 mg) | 4 | 19 |
| Total, other adverse events | D: Ivermectin (200 µg/kg) | 6 | 19 |
| Total, other adverse events | E: Moxidectin (8 mg) | 23 | 80 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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