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
- Are there results?
- Not yet: the study is under way
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).
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07258173
- Acronym / sponsor ID
- EMOTI / EMODEPSIDE_CÔTE_D'IVOIRE
- Conditions
- Trichuris Infection
- Keywords
- Trichuris incognita, emodepside, efficacy, safety, soil transmitted helminths, Trichuris, Côte d'Ivoire
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jennifer KeiserUniversity, hospital or other
- Collaborators
- Centre Suisse de Recherches Scientifiques en Cote d'Ivoire, Université Félix Houphouët-Boigny, Bayer
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emodepside 15mg | Experimental | Drug: Emodepside |
| Albendazole 400 mg | Active comparator | Drug: Albendazole 400 mg |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmodepsideTreatment with 15 mg of emodepside | Drug | Emodepside 15mg |
| Albendazole 400 mgTreatment with 400mg of albendazole | Drug | Albendazole 400 mg |
Primary outcome
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.
2 secondary outcomes
Egg-reduction rate (ERR) of emodepside compared to albendazole against Trichuris incognita
Time frame: Between 14-21 days post-treatment
Safety and tolerability
Time frame: 3- and 24- hours post-treatment and retrospectively 14-21 days post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Trichuris Infection
Not yet recruitingPhase 3
Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections
Trichuris Trichiura; Infection, Hookworm Infection
RecruitingPhase 2
A Safety and Efficacy Study of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole to Treat Trichuris Trichiura Infection in Adults
Trichuriasis
Not yet recruitingPhase 3
Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras
Trichuriasis, Strongyloidiasis
RecruitingPhase 1
Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults
Whipworm, Trichuriasis
Active, not recruiting
Cement flooRs AnD chiLd hEalth (CRADLE)
Ascaris Lumbricoides Infection, Necator Americanus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Emodepside and Albendazole 400 mg in people with Trichuris Infection, run by Jennifer Keiser.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate (CR) of emodepside compared to albendazole against Trichuris incognita (time frame: Between 14-21 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.