Trial intelligence / Profile preview

Moxidectin-albendazole for Trichuris trichiura in children

NCT06188715Phase 3

Key facts

Status
Completed
Start
May 2024
Primary completion
Aug 2024
Countries
1
Modality
Allosteric Modulators
Conditions
trichuriasis
01

Overview

Phase 3, randomised, double-blind trial of moxidectin in trichuriasis (3 arms). Primary endpoint: Cure Rate Against T. Trichiura. Started May 2024; status: completed.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • Moxidectin + Albendazole

    Moxidectin (4/8 mg) + Albendazole (400 mg)

  • Albendazole

    Albendazole (400 mg) + Placebo Moxidectin

  • Placebo

    Placebo Moxidectin + Placebo Albendazole

03

Who it enrols

School-aged children (6-12 years) with confirmed Trichuris trichiura infection (2/4 positive Kato-Katz slides), excluding those with major systemic illness, severe anemia, or recent anthelminthic use.

04

Endpoints

Primary

  • Cure Rate Against T. Trichiura

Secondary

  • Egg Reduction Rate Against T. Trichiura

  • Cure Rate Against A. Lumbricoides

  • Egg Reduction Rate Against A. Lumbricoides

  • Cure Rate Against Hookworm

  • Egg Reduction Rate Against Hookworm

  • Number of Participants Reporting Adverse Events

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