Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients

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

Conditions

• Trichuris Infection
• Helminthiasis

Interventions

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.

Sponsors & Collaborators

• Brock University

  collaborator OTHER

• Universidad Nacional del Centro de la Provincia de Buenos Aires

  collaborator OTHER

• Universidad Nacional Autonoma de Honduras

  collaborator OTHER

• Alejandro Krolewiecki

  lead OTHER

Principal Investigators

• Alejandro J Krolewiecki, MD, PhD · IIET - Universidad Nacional de Salta

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-09

Primary Completion

2020-03-07

Completion

2020-03-07

Countries

• Argentina
• Honduras

Study Locations