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Efficacy, Safety and Acceptability of Ivermectin ODT in PSAC

NCT06184399 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-09-22

Study results available
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Summary

This study is a single-blind randomized controlled dose-ranging trial aiming at providing evidence on the on the optimal dose of co-administered ivermectin and albendazole in terms of efficacy, safety and acceptability in preschool-aged children (PSAC; aged 2-5 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, the pharmacokinetics of the newly developed oro-dispersible tablets (ODTs) and the standard ivermectin tablets (Stromectol®) will be compared in this age group.

As measure of efficacy of the treatment the cure rate (percentage of egg-positive participants at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.

Conditions

  • Trichuriasis
  • Ascariasis
  • Hookworm Infections

Interventions

DRUG

Ivermectin 1.5 mg ODT

Oro-dispersible tablets of 1.5 mg ivermectin

DRUG

Ivermectin 3 mg Oral Tablet

Tablets of 3 mg ivermectin

DRUG

Albendazole 400 mg Oral Tablet

Tablets of 400 mg albendazole

DRUG

Placebo Ivermectin ODT

Placebo for ivermectin ODT

Sponsors & Collaborators

  • Public Health Laboratory Ivo de Carneri

    collaborator OTHER

  • Jennifer Keiser

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-05
Primary Completion
2024-08-09
Completion
2024-08-09

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06184399 on ClinicalTrials.gov