Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients

Helminthiasis Clinical Trial

— HI4T  

Official title:

Prospective, Parallel-group, Open-label Randomized Controlled Trial of Four Treatment Regimes for Trichuriasis in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04041453
• Other study ID #: 01-2019
• Status: Completed
• Phase: Phase 2
• Start date: October 9, 2019
• Est. completion date: March 7, 2020

Study information

• Verified date: July 2020
• Source: Universidad Nacional de Salta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: March 7, 2020
• Est. primary completion date: March 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helminthiasis
• Trichuriasis
• Trichuris Infection

Intervention

Drug:
• Ivermectin
Ivermectin at 600mcg/kg in addition to albendazole will be provided for 1 or 3 days.
• Albendazole
Albendazole will be provided as an active control or in experimental arms for 1 or 3 days with ivermectin.

Locations

Country	Name	City	State
Argentina	IIET	Oran	Salta
Honduras	Universidad Autónoma de Honduras	Tegucigalpa

Sponsors (4)

Lead Sponsor	Collaborator
Alejandro Krolewiecki	Brock University, Universidad Nacional Autonoma de Honduras, Universidad Nacional del Centro de la Provincia de Buenos Aires

Countries where clinical trial is conducted

Argentina,  Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Egg Change Rate	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).	21 days
Secondary	Beta Tubulin Resistance	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.	21days