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

Alejandro Krolewiecki

Status and phase: Completed; Phase 2

Conditions: Helminthiasis; Trichuris Infection

Treatments: Drug: Albendazole; Drug: Ivermectin

Study type: Interventional

Funder types: Other

Identifiers

NCT04041453

01-2019

Details and patient eligibility

About

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

Enrollment: 176 patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 4 patient groups

Albendazole 400mg

Active Comparator group

Description:

Albendazole 400mg in single dose

Treatment:

Drug: Albendazole

Albendazole/Ivermectin

Experimental group

Description:

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

Treatment:

Drug: Ivermectin

Drug: Albendazole

Albendazole 400mg x 3

Experimental group

Description:

Albendazole 400mg/day for 3 consecutive days

Treatment:

Drug: Albendazole

Albendazole/Ivermectin x 3

Experimental group

Description:

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

Treatment:

Drug: Ivermectin

Drug: Albendazole