Trial · NCT04041453

Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients

NCT04041453, Phase 2, Completed, Alejandro Krolewiecki; results first posted 2020-07-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients. Trials, record NCT04041453. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04041453

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients
NCT number: NCT04041453
Status: Completed
Phases: Phase 2
Enrollment: 176 participants, actual
Lead sponsor: Alejandro Krolewiecki
Conditions: Trichuris Infection, Helminthiasis
Interventions: Ivermectin, Albendazole
First posted: 2019-08-01
Last updated: 2020-07-29
Results first posted: 2020-07-29

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cure Rate	21 days	Number of individuals cured from Trichuris trichiura infection using the duplicate Kato Katz laboratory method on a single sample of fresh stools as the measurement tool. Cure rate is defined as the absence of Trichuris trichiura eggs in post-treatment samples.
Secondary	Egg Change Rate	21 days	Calculation details: 100 x (1 - arithmetic mean fecal egg count post-intervention / arithmetic mean fecal egg count pre-intervention) Egg change rate was calculated across all participants, as described in reference: Levecke B et al., PLoS Negl Trop Dis. 2014;8(10).
Secondary	Beta Tubulin Resistance	21days	Measurement of the incidence of mutations of tubulin in Trichuris trichiura eggs collected pre and post treatment using molecular biology techniques. This data is not available yet due to the COVID-19 pandemic, but the data will be available and reported in the future. Anticipated reporting date for this outcome measure is estimated by 2021 and will be confirmed once the pandemic is over.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cure Rate	21 days	The follow-up visit for efficacy assessment on Day 21 post-drug administration was not conducted in 52 subjects due to the outbreak of COVID-19 pandemic in Honduras which precluded completion of study visits in March 2020.~Additional 7 subjects did not complete the study: 1 did not take the study medication, and 6 subjects were lost to follow up.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Egg Change Rate	21 days	The follow-up visit for efficacy assessment on Day 21 post-drug administration was not conducted in 52 subjects due to the outbreak of COVID-19 pandemic in Honduras which precluded completion of study visits in March 2020.~Additional 7 subjects did not complete the study: 1 did not take the study medication, and 6 subjects were lost to follow up.	Percent change	NUMBER
SECONDARY	Beta Tubulin Resistance	21days

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Cure Rate	Albendazole 400mg	1	Participants
Cure Rate	Albendazole/Ivermectin	31	Participants
Cure Rate	Albendazole 400mg x3	6	Participants
Cure Rate	Albendazole/Ivermectin x 3	40	Participants
Egg Change Rate	Albendazole 400mg	50	Percent change
Egg Change Rate	Albendazole/Ivermectin	97	Percent change
Egg Change Rate	Albendazole x 3	72	Percent change
Egg Change Rate	Albendazole/Ivermectin x 3	100	Percent change

Source ClinicalTrials.gov

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Albendazole 400mg	38
Overall Study	STARTED	Albendazole/Ivermectin	57
Overall Study	STARTED	Albendazole 400mg x 3	23
Overall Study	STARTED	Albendazole/Ivermectin x 3	58
Overall Study	Safety Population	Albendazole 400mg	38
Overall Study	Safety Population	Albendazole/Ivermectin	56
Overall Study	Safety Population	Albendazole 400mg x 3	23
Overall Study	Safety Population	Albendazole/Ivermectin x 3	58
Overall Study	COMPLETED	Albendazole 400mg	24
Overall Study	COMPLETED	Albendazole/Ivermectin	35

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events24

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 400mg	0	38	0
other	Abdominal pain	Gastrointestinal disorders	Albendazole/Ivermectin	4	56	4
other	Abdominal pain	Gastrointestinal disorders	Albendazole 400mg x3	2	23	2
other	Abdominal pain	Gastrointestinal disorders	Albendazole/Ivermectin x 3	4	58	4
other	Vomiting	Gastrointestinal disorders	Albendazole 400mg	0	38	0
other	Vomiting	Gastrointestinal disorders	Albendazole/Ivermectin	0	56	0
other	Vomiting	Gastrointestinal disorders	Albendazole 400mg x3	0	23	0
other	Vomiting	Gastrointestinal disorders	Albendazole/Ivermectin x 3	1	58	1
other	Pruritus	Skin and subcutaneous tissue disorders	Albendazole 400mg	0	38	0
other	Pruritus	Skin and subcutaneous tissue disorders	Albendazole/Ivermectin	0	56	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Albendazole 400mg	0	38
Total, all-cause mortality	Albendazole/Ivermectin	0	56
Total, all-cause mortality	Albendazole 400mg x3	0	23
Total, all-cause mortality	Albendazole/Ivermectin x 3	0	58
Total, other adverse events	Albendazole 400mg	0	38
Total, other adverse events	Albendazole/Ivermectin	10	56
Total, other adverse events	Albendazole 400mg x3	7	23
Total, other adverse events	Albendazole/Ivermectin x 3	10	58
Total, serious adverse events	Albendazole 400mg	0	38
Total, serious adverse events	Albendazole/Ivermectin	0	56

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33906234	DERIVED	PubMed
39561184	DERIVED	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04041453

GET https://conductscience.org/api/trials/v1/NCT04041453/events?page=2

API reference For AI assistants