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Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients (HI4T)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04041453
Recruitment Status : Completed
First Posted : August 1, 2019
Results First Posted : July 29, 2020
Last Update Posted : July 29, 2020
Sponsor:
Collaborators:
Brock University
Universidad Nacional del Centro de la Provincia de Buenos Aires
Universidad Nacional Autonoma de Honduras
Information provided by (Responsible Party):
Alejandro Krolewiecki, Universidad Nacional de Salta

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


Condition or disease Intervention/treatment Phase
Trichuris Infection Helminthiasis Drug: Ivermectin Drug: Albendazole Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Parallel-group, Open-label Randomized Controlled Trial of Four Treatment Regimes for Trichuriasis in Pediatric Patients
Actual Study Start Date : October 9, 2019
Actual Primary Completion Date : March 7, 2020
Actual Study Completion Date : March 7, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Albendazole 400mg
Albendazole 400mg in single dose
Drug: Albendazole
Albendazole will be provided as an active control or in experimental arms for 1 or 3 days with ivermectin.

Experimental: Albendazole/Ivermectin
Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose.
Drug: Ivermectin
Ivermectin at 600mcg/kg in addition to albendazole will be provided for 1 or 3 days.

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

Experimental: Albendazole 400mg x 3
Albendazole 400mg/day for 3 consecutive days
Drug: Albendazole
Albendazole will be provided as an active control or in experimental arms for 1 or 3 days with ivermectin.

Experimental: Albendazole/Ivermectin x 3
Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days
Drug: Ivermectin
Ivermectin at 600mcg/kg in addition to albendazole will be provided for 1 or 3 days.

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




Primary Outcome Measures :
  1. Cure Rate [ Time Frame: 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 Outcome Measures :
  1. Egg Change Rate [ Time Frame: 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).

  2. Beta Tubulin Resistance [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04041453


Locations
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Argentina
IIET
Oran, Salta, Argentina, 4530
Honduras
Universidad Autónoma de Honduras
Tegucigalpa, Honduras
Sponsors and Collaborators
Alejandro Krolewiecki
Brock University
Universidad Nacional del Centro de la Provincia de Buenos Aires
Universidad Nacional Autonoma de Honduras
Investigators
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Study Director: Alejandro J Krolewiecki, MD, PhD IIET - Universidad Nacional de Salta
  Study Documents (Full-Text)

Documents provided by Alejandro Krolewiecki, Universidad Nacional de Salta:
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Responsible Party: Alejandro Krolewiecki, Investigador CIC CONICET, Universidad Nacional de Salta
ClinicalTrials.gov Identifier: NCT04041453    
Other Study ID Numbers: 01-2019
First Posted: August 1, 2019    Key Record Dates
Results First Posted: July 29, 2020
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alejandro Krolewiecki, Universidad Nacional de Salta:
TRICHURIS
STH
IVERMECTIN
ALBENDAZOLE
Additional relevant MeSH terms:
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Helminthiasis
Trichuriasis
Parasitic Diseases
Enoplida Infections
Adenophorea Infections
Nematode Infections
Ivermectin
Albendazole
Antiparasitic Agents
Anti-Infective Agents
Anthelmintics
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents