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

Efficacy and Safety of a Single Dose of Emodepside Compared to a Single Dose of Albendazole in Adolescents and Adults Infected With Trichuris Incognita: a Phase II, Randomized, Double Blind, Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Trichuris Infection
• Intervention / Treatment: Drug: Emodepside; Drug: Albendazole 400 mg

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Albendazole 400 mg	Drug: Albendazole 400 mg; Treatment with 400mg of albendazole
Experimental: Emodepside 15mg	Drug: Emodepside; Treatment with 15 mg of emodepside

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure rate (CR) of emodepside compared to albendazole against Trichuris incognita	Trichuris incognita infection status of participants 14-21 days post-treatment assessed by Kato-Katz. CRs will be calculated as the percentage of egg-positive participants at screening who become egg-negative after treatment, for each treatment arm. Differences in CRs between the two treatments will be assessed.	Between 14-21 days post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Egg-reduction rate (ERR) of emodepside compared to albendazole against Trichuris incognita	Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. ERR is caluclated as follows: ERR = (1- (geometric mean EPG at follow-up ÷ geometric mean EPG at baseline)) x 100	Between 14-21 days post-treatment
Safety and tolerability	Tolerability of treatments (adverse events (AEs)) will be assessed at 3- and 24- hours post-treatment and at 14 - 21 days follow up. The safety analysis will be conducted on all participants who were treated and include all available drug safety data. AEs will be evaluated descriptively as the difference between proportions of reported AEs before and after treatment.	3- and 24- hours post-treatment and retrospectively 14-21 days post-treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CR and ERR of emodepside and albendazole against Ascaris lumbricoides and hookworm in co-infected participants	If there are enough co-infections in the sample, exploratory analyses will be performed to assess the difference in cure rates and ERR for hookworm and A. lumbricoides. If there are fewer than 30 participants with co-infections of a certain species in total, the results will only be provided descriptively.	Between 14-21 days post-treatment

Collaborators and Investigators

• Sponsor: Jennifer Keiser
• Collaborators: Bayer; Centre Suisse de Recherches Scientifiques en Cote d'Ivoire; Université Félix Houphouët-Boigny

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: safety; efficacy; soil transmitted helminths; Trichuris; Côte d'Ivoire; Trichuris incognita; emodepside
• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Nematode Infections; Helminthiasis; Enoplida Infections; Adenophorea Infections; Trichuriasis; Organic Chemicals; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Acids, Acyclic; Carboxylic Acids; Carbamates; Albendazole; emodepside
• Other Study ID Numbers: EMODEPSIDE_CÔTE_D'IVOIRE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No