Trial · NCT03527732
Efficacy and Safety of IVM/ALB Co-administration
NCT03527732, Phase 2, Phase 3, Completed, Jennifer Keiser; results first posted 2024-03-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of IVM/ALB Co-administration. Trials, record NCT03527732. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03527732
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of IVM/ALB Co-administration
- NCT number
- NCT03527732
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,673 participants, actual
- Lead sponsor
- Jennifer Keiser
- Conditions
- Trichuriasis
- Interventions
- Albendazole, Albendazole and Ivermectin
- First posted
- 2018-05-17
- Last updated
- 2024-03-20
- Results first posted
- 2024-03-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) | 14-21 days after treatment | The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR). |
| Secondary | Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) After 6 and 12 Months Post Treatment | 6 and 12 months after treatment | Conversion of T. trichiura egg-positive participants at baseline who become egg-negative 6 and 12 months after treatment. |
| Secondary | Egg-reduction Rate (ERR) Against T. Trichiura | 14-21 days, 6 months and 12 months after 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 With Concomitant Soil-transmitted Helminth Infections Egg Negative Post-Treatment (Cured) | 14-21 days, 6 months and 12 months after treatment | Number of participants that converted from egg positive with Ascaris lumbricoides, hookworm and/or Strongyloides stercoralis infections to egg negative after 14-21 days. Number of egg-negatives at 6 and 12 months after treatment. |
| Secondary | Egg-reduction Rates (ERRs) Against Concomitant Soil-transmitted Helminth Infections. | 14-21 days, 6 months and 12 months after treatment | Percent change in geometric mean eggs per gram of stool from before to after treatment. ERRs will be calculated for Ascaris lumbricoides and hookworm infections as described in outcome 3. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) | 14-21 days after treatment | An analysis set of all randomized participants who provided any follow-up data was used to perform an available-case analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) After 6 and 12 Months Post Treatment | 6 and 12 months after treatment | An analysis set of all randomized participants who provided any follow-up data at 6 or 12 months post treatment was used to perform an available-case analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Egg-reduction Rate (ERR) Against T. Trichiura | 14-21 days, 6 months and 12 months after treatment | Overall number of participants analyzed corresponds to all participants that got randomized. An analysis set of all randomized participants who provided any follow-up data was used to perform an available-case analysis for each assessment time point (i.e., 14-21 days, 6 months and 12 months post-treatment). | percent of change | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Concomitant Soil-transmitted Helminth Infections Egg Negative Post-Treatment (Cured) | 14-21 days, 6 months and 12 months after treatment | Overall number of participants include all randomized participants. To assess the number of cured 14-21 days post-treatment only randomized baseline egg positive participants with follow-up stool data were considered. For the 6 and 12 month assessment all randomized participants with at least one stool sample analyzed were considered. The number cured as assessed 14-21 days post-treatment provides a proportion that is considered the cure rate (conversion rate from positive to negative). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Egg-reduction Rates (ERRs) Against Concomitant Soil-transmitted Helminth Infections. | 14-21 days, 6 months and 12 months after treatment | An analysis set of all randomized participants who provided any follow-up data (14-21 days, 6 or 12 months post treatment) was used to perform an available-case analysis. | percent of change | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group92
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) | Albendazole in Côte d'Ivoire | Cured | 24 | Participants | |
| Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) | Albendazole and Ivermectin in Côte d'Ivoire | Cured | 32 | Participants | |
| Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) | Albendazole in Laos | Cured | 16 | Participants | |
| Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) | Albendazole and Ivermectin in Laos | Cured | 140 | Participants | |
| Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) | Albendazole in Pemba Island | Cured | 18 | Participants | |
| Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) | Albendazole and Ivermectin in Pemba Island | Cured | 140 | Participants | |
| Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) | Albendazole in Côte d'Ivoire | Not cured | 211 | Participants | |
| Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) | Albendazole and Ivermectin in Côte d'Ivoire | Not cured | 200 | Participants | |
| Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) | Albendazole in Laos | Not cured | 178 | Participants | |
| Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) | Albendazole and Ivermectin in Laos | Not cured | 73 | Participants |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Albendazole in Côte d'Ivoire | 256 | |
| Overall Study | STARTED | Albendazole and Ivermectin in Côte d'Ivoire | 255 | |
| Overall Study | STARTED | Albendazole in Laos | 274 | |
| Overall Study | STARTED | Albendazole and Ivermectin in Laos | 275 | |
| Overall Study | STARTED | Albendazole in Pemba Island | 305 | |
| Overall Study | STARTED | Albendazole and Ivermectin in Pemba Island | 308 | |
| Overall Study | COMPLETED | Albendazole in Côte d'Ivoire | 235 | |
| Overall Study | COMPLETED | Albendazole and Ivermectin in Côte d'Ivoire | 232 | |
| Overall Study | COMPLETED | Albendazole in Laos | 194 | |
| Overall Study | COMPLETED | Albendazole and Ivermectin in Laos | 213 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events48
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 | Albendazole in Côte d'Ivoire | 33 | 254 | 35 |
| other | Abdominal pain | Gastrointestinal disorders | Albendazole and Ivermectin in Côte d'Ivoire | 31 | 254 | 32 |
| other | Abdominal pain | Gastrointestinal disorders | Albendazole in Laos | 20 | 273 | 22 |
| other | Abdominal pain | Gastrointestinal disorders | Albendazole and Ivermectin in Laos | 10 | 273 | 10 |
| other | Abdominal pain | Gastrointestinal disorders | Albendazole in Pemba Island | 15 | 305 | 15 |
| other | Abdominal pain | Gastrointestinal disorders | Albendazole and Ivermectin in Pemba Island | 7 | 308 | 8 |
| other | Allergic reaction | Skin and subcutaneous tissue disorders | Albendazole in Côte d'Ivoire | 9 | 254 | 9 |
| other | Allergic reaction | Skin and subcutaneous tissue disorders | Albendazole and Ivermectin in Côte d'Ivoire | 11 | 254 | 11 |
| other | Allergic reaction | Skin and subcutaneous tissue disorders | Albendazole in Laos | 0 | 273 | 0 |
| other | Allergic reaction | Skin and subcutaneous tissue disorders | Albendazole and Ivermectin in Laos | 0 | 273 | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Albendazole in Côte d'Ivoire | 0 | 254 |
| Total, all-cause mortality | Albendazole and Ivermectin in Côte d'Ivoire | 0 | 254 |
| Total, all-cause mortality | Albendazole in Laos | 0 | 273 |
| Total, all-cause mortality | Albendazole and Ivermectin in Laos | 0 | 273 |
| Total, all-cause mortality | Albendazole in Pemba Island | 0 | 305 |
| Total, all-cause mortality | Albendazole and Ivermectin in Pemba Island | 0 | 308 |
| Total, other adverse events | Albendazole in Côte d'Ivoire | 83 | 254 |
| Total, other adverse events | Albendazole and Ivermectin in Côte d'Ivoire | 99 | 254 |
| Total, other adverse events | Albendazole in Laos | 77 | 273 |
| Total, other adverse events | Albendazole and Ivermectin in Laos | 72 | 273 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers5
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.
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/NCT03527732
GET https://conductscience.org/api/trials/v1/NCT03527732/results?page=2