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NCT Number: NCT07258173

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

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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Key information

Conditions

Trichuris Infection Adenophorea Infections Enoplida Infections Helminthiasis Infections Nematode Infections Parasitic Diseases Trichuriasis

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Emodepside

Drug

Treatment with 15 mg of emodepside

Albendazole 400 mg

Drug

Treatment with 400mg of albendazole

Primary outcomes

  1. Cure rate (CR) of emodepside compared to albendazole against Trichuris incognita

    Time frame: Between 14-21 days post-treatment

    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.

Secondary outcomes

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

    Time frame: Between 14-21 days post-treatment

    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

  2. Safety and tolerability

    Time frame: 3- and 24- hours post-treatment and retrospectively 14-21 days post-treatment

    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.

Other outcomes

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

    Time frame: Between 14-21 days post-treatment

    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.

Sponsors and collaborators

Lead sponsor

Jennifer Keiser

Other

Collaborators

  • Bayer
  • Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
  • Université Félix Houphouët-Boigny

Registry information

Official study title

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

Acronym: EMOTI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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