Evaluation of Effectiveness of ALBENDAZOLIVERMECTIN Coformulation vs ALBENDAZOLE for Treatment of Intestinal Worms

Summary

The purpose of this clinical trial is to evaluate a fixed-dose co-formulation (FDC) of ivermectin and albendazole for the treatment of all Soil Transmitted helminths (STH). The current strategy to control STH in endemic areas is mass administration of albendazole or mebendazole, mainly to pre-school and school-aged children.

Although this treatment works well for some STH species, efficacy against Trichuris trichiura is poor and it is not effective Strongyloides stercoralis. Thus new drugs or drug combinations are an urgent priority to increase the effectiveness of control programmes. Furthermore, the World Health Organisation has recommended combination therapy of ivermectin with albendazole. The trial proposed, is an adaptive phase II/III trial where the phase II component will evaluate the safety of the FDC as a single dose or 3-day single dose regimen for the treatment of T. trichiura in paediatric population. After analysis of the safety results the phase III trial will be executed to evaluate the efficacy of the FDC as a single dose or 3-day single dose regimen compared to the standard single dose regimen of ALB (400 mg) for the treatment of T. trichiura, hookworm and S. stercoralis in paediatric and young adult population. The estimated total sample size for the adaptive design (phase II and III component) is 1223 participants. Of these, 126 will be enrolled in the phase II and 1097 in the phase III components respectively in an adaptive trial design.

Conditions

• Helminthes; Infestation, Intestinal

Interventions

COMBINATION_PRODUCT

Albendazole and Ivermectin fixed dose coformulation

400 mg Albendazole - 9 mg Ivermectin OR 400 mg Albendazole - 18 mg Ivermectin

DRUG

Albendazole

Albendazole 400mg single dose

Sponsors & Collaborators

• Leiden University Medical Center

  collaborator OTHER

• Bahir Dar University

  collaborator OTHER

• Centro de Investigacao em Saude de Manhica

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Kenya Medical Research Institute

  collaborator OTHER

• Laboratorios Liconsa

  collaborator INDUSTRY

• Universidad de León

  collaborator OTHER

• European and Developing Countries Clinical Trials Partnership (EDCTP)

  collaborator OTHER_GOV

• Barcelona Institute for Global Health

  lead OTHER

Principal Investigators

• Jose Munoz, MD, PhD · Barcelona institue for Global health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-20

Primary Completion

2023-03-21

Completion

2023-03-24

Countries

• Ethiopia
• Kenya
• Mozambique

Study Locations