Trichuris InfectionPhase 2EMOTINCT07258173
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 2 study testing Emodepside and Albendazole 400 mg in people with Trichuris Infection, run by Jennifer Keiser.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Trichuris Infection
- What is being tested?
- Emodepside and Albendazole 400 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 15 Feb 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
About this study
Official 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
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
- Being tested
- Emodepside, Albendazole 400 mg
- Keywords
- Trichuris incognita, emodepside, efficacy, safety, soil transmitted helminths, Trichuris, Côte d'Ivoire
- Medical subject headings
- Trichuriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmodepsideDrug
Treatment with 15 mg of emodepside
Albendazole 400 mgDrug
Treatment with 400mg of albendazole
| Study group | Role | What they receive |
|---|---|---|
| Emodepside 15mg | Experimental | Not described Receives: Drug: Emodepside |
| Albendazole 400 mg | Active comparator | Not described Receives: Drug: Albendazole 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between 14-21 days post-treatment
Secondary outcomes (2)
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
Measured: 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.
Measured: 3- and 24- hours post-treatment and retrospectively 14-21 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start15 Nov 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trichuris InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jennifer Keiser
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Suisse de Recherches Scientifiques en Cote d'Ivoire, Université Félix Houphouët-Boigny, Bayer
- Responsible party
- Sponsor-investigator, Jennifer Keiser, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258173
- Sponsor's protocol ID
- EMODEPSIDE_CÔTE_D'IVOIRE
- Acronym
- EMOTI
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No