NCT04041453

Brief Summary

There are four species of intestinal worms collectively known as soil-transmitted helminthiasis (STH): Ancylostoma duodenale and Necator americanus (hookworms), Ascaris lumbricoides (roundworms), and Trichuris trichiura (whipworms). These parasites affect over two billion people and contribute to significant morbidity and disability, especially in high risk groups, for example children, agricultural workers and pregnant women. In children, STH are associated with impaired nutritional status evidenced by stunting, thinness and underweight. As is the case in most Latin America, STH are a public health problem in Honduras. The World Health Organization (WHO) informs that more than 2.5 million children (under 15 years of age) in the country are at risk of infection. To control these infections Honduras has established a national deworming program that operates since 2001 but despite these efforts, the prevalence of STH infections remains unacceptably high. This is especially true in rural communities where prevalence can be as high as 70% of the children population. Ivermectin (IVM) in combination with albendazole (ALB) has demonstrated the capacity to improve efficacy compared to any of these drugs in monotherapy; the efficacy is however, still inadequate in terms of cure rate, although egg reduction rates are significant. The purpose of the current trial is to assess the safety and efficacy of 3 experimental regimens for the treatment of infections by Trichuris trichiura in children in comparison with the current standard of practice in Mass Drug Administration (MDA) campaigns. The experimental regimens will explore the effect of multiple day regimens and high dose ivermectin. Treatment arms:

  • Group 1: single dose of ALB 400 mg. (active control arm). N:39
  • Group 2: single dose ALB 400mg + IVM 600µg/Kg. N: 57
  • Group 3: daily dose ALB 400mg for 3 consecutive days. N:24
  • Group 4: daily dose ALB 400mg + IVM 600µg for 3 consecutive days. N:57 Total Study Population: 177

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2019

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 9, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2020

Completed
5 months until next milestone

Results Posted

Study results publicly available

July 29, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

July 22, 2019

Results QC Date

May 8, 2020

Last Update Submit

July 27, 2020

Conditions

Trichuris InfectionHelminthiasis

Keywords

TRICHURISSTHIVERMECTINALBENDAZOLE

Outcome Measures

Primary Outcomes (1)

  • Cure Rate

    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.

    21 days

Secondary Outcomes (2)

  • Egg Change Rate

    21 days

  • Beta Tubulin Resistance

    21days

Study Arms (4)

Albendazole 400mg

ACTIVE COMPARATOR

Albendazole 400mg in single dose

Drug: Albendazole

Albendazole/Ivermectin

EXPERIMENTAL

Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose.

Drug: IvermectinDrug: Albendazole

Albendazole 400mg x 3

EXPERIMENTAL

Albendazole 400mg/day for 3 consecutive days

Drug: Albendazole

Albendazole/Ivermectin x 3

EXPERIMENTAL

Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days

Drug: IvermectinDrug: Albendazole

Interventions

IvermectinDRUG

Ivermectin at 600mcg/kg in addition to albendazole will be provided for 1 or 3 days.

Albendazole/IvermectinAlbendazole/Ivermectin x 3
AlbendazoleDRUG

Albendazole will be provided as an active control or in experimental arms for 1 or 3 days with ivermectin.

Albendazole 400mgAlbendazole 400mg x 3Albendazole/IvermectinAlbendazole/Ivermectin x 3

Eligibility Criteria

Age2 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infection with T. trichiura by Kato Katz.
  • Body weight \>15kg.
  • Accepts participation

You may not qualify if:

  • Albendazole and/or mebendazol treatment in the previous 3 months.
  • Allergy to the study drugs
  • Acute medical conditions
  • Clinical trial participation in the previous 3 months.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IIET

Orán, Salta Province, 4530, Argentina

Location

Universidad Autónoma de Honduras

Tegucigalpa, Honduras

Location

Related Publications (2)

  • Matamoros G, Sanchez A, Cimino R, Krolewiecki A, Mejia R. A comparison of the diagnostic capability of Kato-Katz and real-time PCR for the assessment of treatment efficacy of ivermectin and albendazole combination against T. trichiura infections. PLoS Negl Trop Dis. 2024 Nov 19;18(11):e0012677. doi: 10.1371/journal.pntd.0012677. eCollection 2024 Nov.

    PMID: 39561184DERIVED

  • Matamoros G, Sanchez A, Gabrie JA, Juarez M, Ceballos L, Escalada A, Rodriguez C, Marti-Soler H, Rueda MM, Canales M, Lanusse C, Cajal P, Alvarez L, Cimino RO, Krolewiecki A. Efficacy and Safety of Albendazole and High-Dose Ivermectin Coadministration in School-Aged Children Infected With Trichuris trichiura in Honduras: A Randomized Controlled Trial. Clin Infect Dis. 2021 Oct 5;73(7):1203-1210. doi: 10.1093/cid/ciab365.

    PMID: 33906234DERIVED

MeSH Terms

Conditions

TrichuriasisHelminthiasis

Interventions

IvermectinAlbendazole

Condition Hierarchy (Ancestors)

Enoplida InfectionsAdenophorea InfectionsNematode InfectionsParasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsCarbamatesAcids, AcyclicCarboxylic AcidsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Alejandro J Krolewiecki
Organization
Universidad Nacional de Salta
alekrol@hotmail.com
+54 911 3183-8673

Study Officials

  • Alejandro J Krolewiecki, MD, PhD

    IIET - Universidad Nacional de Salta

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigador CIC CONICET

Study Record Dates

First Submitted

July 22, 2019

First Posted

August 1, 2019

Study Start

October 9, 2019

Primary Completion

March 7, 2020

Study Completion

March 7, 2020

Last Updated

July 29, 2020

Results First Posted

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication.

Shared Documents
ANALYTIC CODE
Time Frame
After study data analysis completion, with submission for publication to a peer review journal..
Access Criteria
Database will be made available through a publication.

Locations

AR(1)HO(1)