Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients

Phase 2

Completed

Conditions: Trichuris Infection
Helminthiasis

Interventions: Drug: Ivermectin
Drug: Albendazole

Registration Number: NCT04041453

Lead Sponsor: Alejandro Krolewiecki

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 176

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Albendazole/Ivermectin	Albendazole	Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose.
Albendazole/Ivermectin	Ivermectin	Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose.
Albendazole/Ivermectin x 3	Ivermectin	Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days
Albendazole 400mg	Albendazole	Albendazole 400mg in single dose
Albendazole 400mg x 3	Albendazole	Albendazole 400mg/day for 3 consecutive days
Albendazole/Ivermectin x 3	Albendazole	Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days

Primary Outcome Measures

Name	Time	Method
Cure Rate	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

Name	Time	Method
Egg Change Rate	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).
Beta Tubulin Resistance	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.