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

NCT07258173 | Not Yet Recruiting Phase 2

• 1 other identifier: EMODEPSIDE_CÔTE_D'IVOIRE
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Trichuris Infection; Trichuris

Keywords

Trichuris incognita; emodepside; efficacy; safety; soil transmitted helminths; Trichuris; Côte d'Ivoire

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Egg-reduction rate (ERR) of emodepside compared to albendazole against Trichuris incognita

  Between 14-21 days post-treatment

• Safety and tolerability

  3- and 24- hours post-treatment and retrospectively 14-21 days post-treatment

Other Outcomes (1)

• CR and ERR of emodepside and albendazole against Ascaris lumbricoides and hookworm in co-infected participants

  Between 14-21 days post-treatment

Study Arms (2)

Emodepside 15mg

EXPERIMENTAL

Drug: Emodepside

Albendazole 400 mg

ACTIVE COMPARATOR

Drug: Albendazole 400 mg

Interventions

Emodepside DRUG

Treatment with 15 mg of emodepside

Emodepside 15mg

Albendazole 400 mg DRUG

Treatment with 400mg of albendazole

Albendazole 400 mg

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Trichuriasis

Interventions

emodepside; Albendazole

Condition Hierarchy (Ancestors)

Enoplida Infections; Adenophorea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11