Trial · NCT06184399
Efficacy, Safety and Acceptability of Ivermectin ODT in PSAC
NCT06184399, Phase 2, Completed, Jennifer Keiser; results first posted 2025-09-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy, Safety and Acceptability of Ivermectin ODT in PSAC. Trials, record NCT06184399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06184399
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety and Acceptability of Ivermectin ODT in PSAC
- NCT number
- NCT06184399
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 260 participants, actual
- Lead sponsor
- Jennifer Keiser
- Conditions
- Trichuriasis, Ascariasis, Hookworm Infections
- Interventions
- Ivermectin 1.5 mg ODT, Ivermectin 3 mg Oral Tablet, Albendazole 400 mg Oral Tablet, Placebo Ivermectin ODT
- First posted
- 2023-12-28
- Last updated
- 2025-09-22
- Results first posted
- 2025-09-22
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cure Rate (CR) Against T. Trichiura | 14-21 days post-treatment | The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment. |
| Secondary | Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR) | 14-21 days post-treatment | 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 two treatment arms before and after treatment to assess the corresponding ERRs. |
| Secondary | Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR) | 14-21 days post-treatment | 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 two treatment arms before and after treatment to assess the corresponding ERRs. |
| Secondary | Cure Rate (CR) Against A. Lumbricoides | 14-21 days post-treatment | The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment. |
| Secondary | Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR) | 14-21 days post-treatment | 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 two treatment arms before and after treatment to assess the corresponding ERRs. |
| Secondary | Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR) | 14-21 days post-treatment | 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 two treatment arms before and after treatment to assess the corresponding ERRs. |
| Secondary | Cure Rate (CR) Against Hookworm | 14-21 days post-treatment | The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment. |
| Secondary | Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR) | 14-21 days post-treatment | 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 two treatment arms before and after treatment to assess the corresponding ERRs. |
| Secondary | Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR) | 14-21 days post-treatment | 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 two treatment arms before and after treatment to assess the corresponding ERRs. |
| Secondary | Number of Participants Reporting Adverse Events (AEs) | 3 hours, 24 hours and 14-21 days post-treatment | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cure Rate (CR) Against T. Trichiura | 14-21 days post-treatment | Available case population | percentage of participants cured (%) | NUMBER |
| SECONDARY | Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR) | 14-21 days post-treatment | Available case population. | percent change in egg counts (%) | GEOMETRIC_MEAN |
| SECONDARY | Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR) | 14-21 days post-treatment | Available case population. | percent change in egg counts (%) | MEAN |
| SECONDARY | Cure Rate (CR) Against A. Lumbricoides | 14-21 days post-treatment | Subset of participants co-infected with A. lumbricoides at baseline and providing follow-up data. | percentage of participants cured (%) | NUMBER |
| SECONDARY | Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR) | 14-21 days post-treatment | Subset of participants co-infected with A. lumbricoides at baseline and providing follow-up data. | percent change in egg counts (%) | GEOMETRIC_MEAN |
| SECONDARY | Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR) | 14-21 days post-treatment | Subset of participants co-infected with A. lumbricoides at baseline and providing follow-up data. | percent change in egg counts (%) | MEAN |
| SECONDARY | Cure Rate (CR) Against Hookworm | 14-21 days post-treatment | Subset of participants co-infected with hookworm at baseline and providing follow-up data. | percentage of participants cured (%) | NUMBER |
| SECONDARY | Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR) | 14-21 days post-treatment | Subset of participants co-infected with hookworm at baseline and providing follow-up data. | percent change in egg counts (%) | GEOMETRIC_MEAN |
| SECONDARY | Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR) | 14-21 days post-treatment | Subset of participants co-infected with hookworm at baseline and providing follow-up data. | percent change in egg counts (%) | MEAN |
| SECONDARY | Number of Participants Reporting Adverse Events (AEs) | 3 hours, 24 hours and 14-21 days post-treatment | All participants receiving treatment. | participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cure Rate (CR) Against T. Trichiura | Arm A: Ivermectin ODT Placebo & Albendazole | 17.5 | 95% Confidence Interval 7.3 to 32.8 | percentage of participants cured (%) | |
| Cure Rate (CR) Against T. Trichiura | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | 50.0 | 95% Confidence Interval 34.2 to 65.8 | percentage of participants cured (%) | |
| Cure Rate (CR) Against T. Trichiura | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | 83.3 | 95% Confidence Interval 68.6 to 93.0 | percentage of participants cured (%) | |
| Cure Rate (CR) Against T. Trichiura | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | 84.6 | 95% Confidence Interval 69.5 to 94.1 | percentage of participants cured (%) | |
| Cure Rate (CR) Against T. Trichiura | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | 90.0 | 95% Confidence Interval 76.3 to 97.2 | percentage of participants cured (%) | |
| Cure Rate (CR) Against T. Trichiura | Arm F: Ivermectin Standard Tablets & Albendazole | 73.8 | 95% Confidence Interval 58.0 to 86.1 | percentage of participants cured (%) | |
| Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR) | Arm A: Ivermectin ODT Placebo & Albendazole | 65.5 | 95% Confidence Interval 30.5 to 83.5 | percent change in egg counts (%) | |
| Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR) | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | 97.2 | 95% Confidence Interval 93.9 to 98.8 | percent change in egg counts (%) | |
| Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR) | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | 99.7 | 95% Confidence Interval 99.2 to 99.9 | percent change in egg counts (%) | |
| Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR) | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | 99.7 | 95% Confidence Interval 99.1 to 99.9 | percent change in egg counts (%) |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Ivermectin ODT Placebo & Albendazole | 43 | |
| Overall Study | STARTED | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | 44 | |
| Overall Study | STARTED | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | 42 | |
| Overall Study | STARTED | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | 44 | |
| Overall Study | STARTED | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | 44 | |
| Overall Study | STARTED | Arm F: Ivermectin Standard Tablets & Albendazole | 43 | |
| Overall Study | COMPLETED | Arm A: Ivermectin ODT Placebo & Albendazole | 40 | |
| Overall Study | COMPLETED | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | 42 | |
| Overall Study | COMPLETED | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | 42 | |
| Overall Study | COMPLETED | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | 39 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events18
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 | Arm A: Ivermectin ODT Placebo & Albendazole | 3 | 43 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | 3 | 44 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | 1 | 42 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | 1 | 44 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | 2 | 44 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Arm F: Ivermectin Standard Tablets & Albendazole | 1 | 43 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Arm A: Ivermectin ODT Placebo & Albendazole | 1 | 43 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | 0 | 44 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | 0 | 42 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | 0 | 44 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Ivermectin ODT Placebo & Albendazole | 0 | 43 |
| Total, all-cause mortality | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | 0 | 44 |
| Total, all-cause mortality | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | 0 | 42 |
| Total, all-cause mortality | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | 0 | 44 |
| Total, all-cause mortality | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | 0 | 44 |
| Total, all-cause mortality | Arm F: Ivermectin Standard Tablets & Albendazole | 0 | 43 |
| Total, other adverse events | Arm A: Ivermectin ODT Placebo & Albendazole | 4 | 43 |
| Total, other adverse events | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | 3 | 44 |
| Total, other adverse events | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | 1 | 42 |
| Total, other adverse events | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | 1 | 44 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40975108 | 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 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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