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Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections

NCT06736691 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2026-05-14

No results posted yet for this study

Summary

This study aims to assess the efficacy and safety of emodepside compared to mebendazole in adults and adolescents infected with T. trichiura, either as single infection or co-infections with hookworm and/or A. lumbricoides.

Conditions

  • Trichuris Trichiura; Infection
  • Hookworm Infection
  • Ascaris Lumbricoides Infection

Interventions

DRUG

emodepside (BAY 44-4400)

Treatment with single dose of oral 15 mg emodepside

DRUG

matching placebo of emodepside

Treatment with single dose of oral emodepside matching placebo

DRUG

Mebendazole

Treatment with 100 mg mebendazole orally administered b.i.d. for 3 days

DRUG

similar placebo to mebendazole

Treatment with mebendazole similar placebo orally administered b.i.d. for 3 days

Sponsors & Collaborators

  • Public Health Laboratory Ivo de Carneri

    collaborator OTHER

  • Bayer

    collaborator INDUSTRY

  • Silicon Valley Community Foundation

    collaborator OTHER

  • Swiss Tropical & Public Health Institute

    lead OTHER

Principal Investigators

  • Jennifer Keiser, Professor · Swiss Tropical & Public Health Institute

  • Said Mohammed Ali, MSc · Public Health Laboratory Ivo de Carneri

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-25
Primary Completion
2026-07-31
Completion
2026-10-31

Countries

  • Tanzania

Study Locations

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Entities

Companies

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 NCT06736691 on ClinicalTrials.gov