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Efficacy and Safety of a Sing...

Efficacy and Safety of a Single Dose of Emodepside Compared to a Single Dose of Albendazole in Adolescents and Adults Infected With Trichuris Incognita

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2026-05-15

Brief Summary

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The purpose of this clinical trial is to compare the efficacy and safety of emodepside, with the standard treatment, albendazole, in adolescents (12 years and older) and adults infected with Trichuris incognita.

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Detailed Description

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Conditions

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Trichuris Infection Trichuris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Emodepside 15mg

Group Type EXPERIMENTAL

Emodepside

Intervention Type DRUG

Treatment with 15 mg of emodepside

Albendazole 400 mg

Group Type ACTIVE_COMPARATOR

Albendazole 400 mg

Intervention Type DRUG

Treatment with 400mg of albendazole

Interventions

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Emodepside

Treatment with 15 mg of emodepside

Intervention Type DRUG

Albendazole 400 mg

Treatment with 400mg of albendazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged 12 years and above.
* Written informed consent signed by participant and, in the case of minors, parents/caregivers.
* Agree to comply with study procedures, including provision of two stool samples at the beginning (screening) and at follow-up assessment 14-21 days after treatment.
* Having at least two slides of the quadruple Kato-Katz thick smears positive for Trichuris incognita and infection intensities of at least 48 eggs per gram (EPG).
* Willing to be examined by a study physician prior to treatment.

Exclusion Criteria

* Presence or signs of major systemic illnesses, e.g. body temperature ≥ 38 °C, severe anemia (Hb below 80g/l) upon initial clinical assessment etc.
* History of severe acute or unmanaged severe chronic disease (i.e., condition is not as therapeutically controlled as necessary).
* Positive malaria rapid diagnostic test (RDT) and temperature ≥ 38 °C.
* Abnormal liver and renal function assessed by biochemical blood-based analyses
* Recent use of anthelmintic drugs (in the 4 weeks before treatment).
* Known allergy to study medications and formulations (i.e., albendazole and emodepside).
* Prescribed or taking medication with known contraindication to or interaction with study drugs.
* Participating in other clinical trials during the study period.
* Pregnancy or breastfeeding

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers