Clinical trial NCT04041453: Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients
Official title: Prospective, Parallel-group, Open-label Randomized Controlled Trial of Four Treatment Regimes for Trichuriasis in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Trichuris Infection
Helminthiasis
Keywords: TRICHURIS
STH
IVERMECTIN
ALBENDAZOLE
Lead sponsor: Universidad Nacional de Salta
Sponsor class: OTHER
Collaborators: name: Brock University
name: Universidad Nacional del Centro de la Provincia de Buenos Aires
name: Universidad Nacional Autonoma de Honduras
First posted: 2019-08-01
Enrollment: 176
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Cure Rate
timeFrame: 21 days
Secondary outcomes:
measure: Egg Change Rate
timeFrame: 21 days
measure: Beta Tubulin Resistance
timeFrame: 21days
Other outcomes:
Locations:
city: Oran
country: Argentina
facility: IIET
state: Salta
city: Tegucigalpa
country: Honduras
facility: Universidad Autónoma de Honduras
Study officials:
affiliation: IIET - Universidad Nacional de Salta
name: Alejandro J Krolewiecki, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Matamoros G, Sanchez A, Gabrie JA, Juarez M, Ceballos L, Escalada A, Rodriguez C, Marti-Soler H, Rueda MM, Canales M, Lanusse C, Cajal P, Alvarez L, Cimino RO, Krolewiecki A. Efficacy and Safety of Albendazole and High-Dose Ivermectin Coadministration in School-Aged Children Infected With Trichuris trichiura in Honduras: A Randomized Controlled Trial. Clin Infect Dis. 2021 Oct 5;73(7):1203-1210. doi: 10.1093/cid/ciab365.