Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-09

Study Completion Date

2020-03-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy, Safety and Acceptability of Ivermectin ODT in PSAC

NCT06184399

Trichuriasis Ascariasis Hookworm Infections

COMPLETED PHASE2

Albendazole Dose Finding and Pharmacokinetics in Children and Adults

NCT03527745

Trichuriasis Hookworm Infections

COMPLETED PHASE2

Efficacy and Safety of IVM/ALB Co-administration

NCT03527732

Trichuriasis

COMPLETED PHASE2/PHASE3

Assessing the Safety and Efficacy of a Combination Therapy for STH in PSAC in Bangladesh

NCT07045493

Soil Transmitted Helminth (STH) Infections

ENROLLING_BY_INVITATION PHASE2

Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections

NCT00207753

Ascariasis Trichuriasis Hookworm Infection +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trichuris Infection Helminthiasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

* 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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No