Trichuris Trichiura; InfectionPhase 2EMODEP_PEMBANCT05017194
Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm
A Phase 2 study testing Emodepside in people with Trichuris Trichiura; Infection and Hookworm Infections, run by Jennifer Keiser at 1 site in Tanzania.
Trial summary
The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Trichuris Trichiura; Infection, Hookworm Infections
- What is being tested?
- Emodepside
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 442 participants
- Where
- 1 siteTanzania
- Study dates
- 2 Aug 2021to 10 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female adults aged between 18 and 45 years
- Written and signed informed consent
- Examined by a study physician before treatment
- Provided two stool samples at baseline
- Trichuris trichiura and hookworm EPG ≥ 48 and at least two Kato-Katz thick smears slides with more than one Trichuris trichiura and hookworm eggs
Who cannot join
- Pregnant or lactating and/or planning to become pregnant within three months after drug treatment
- Type 1 and/or 2 diabetes
- Psychiatric disorders
- History of ophthalmological conditions
- Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, during initial clinical assessment
- Suffers from severe anaemia (Hb < 80 g/l)
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- Received anthelminthic treatment within past four weeks
- Attending other clinical trials during the study
- Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin
- Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm: Randomized Two Stages Phase II Seamless Adaptive Controlled Single-blind Trials
The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm.
- Being tested
- Emodepside
- Keywords
- Emodepside, Trichuris trichiura, Hookworm, Soil-transmitted helminths, Efficacy, Safety, Dose selection
- Medical subject headings
- Trichuriasis, Hookworm Infections, Ancylostomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmodepsideDrug
Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Emodepside 5 mg | Experimental | Not described Receives: Drug: Emodepside |
| Emodepside 10 mg | Experimental | Not described Receives: Drug: Emodepside |
| Emodepside 15 mg | Experimental | Not described Receives: Drug: Emodepside |
| Emodepside 20 mg | Experimental | Not described Receives: Drug: Emodepside |
| Emodepside 25 mg | Experimental | Not described Receives: Drug: Emodepside |
| Emodepside 30 mg | Experimental | Not described Receives: Drug: Emodepside |
| Albendazole | Active comparator | Not described Receives: Drug: Emodepside |
| Placebo | Placebo comparator | Not described Receives: Drug: Emodepside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate (CR) of emodepside against Trichuris trichiura
CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment.
Measured: In the week between 14 and 21 days post-treatment
Cure rate (CR) of emodepside against hookworm
CR will be calculated as the percentage of hookworm egg-positive participants at baseline who become egg-negative after treatment.
Measured: In the week between 14 and 21 days post-treatment
Secondary outcomes (3)
Geometric Mean Egg Reduction Rate (ERR) of the emodepside against Trichuris trichiura and hookworm.
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. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100).
Measured: In the week between 14 and 21 days post-treatment
CR against Ascaris lumbricoides
CR will be calculated as the percentage of Ascaris lumbricoides egg-positive participants at baseline who become egg-negative after treatment.
Measured: In the week between 14 and 21 days post-treatment
ERR against Ascaris lumbricoides
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. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100).
Measured: In the week between 14 and 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 posted23 Aug 2021
- Study start2 Aug 2021
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trichuris Trichiura; 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Keiser
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri
- Responsible party
- Sponsor-investigator, Jennifer Keiser, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017194
- Sponsor's protocol ID
- EMODEP_PEMBA
- Acronym
- EMODEP_PEMBA
- Status last verified
- May 2022
- First submitted
- 5 Jul 2021
- Last updated
- 27 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Montresor A, Gabrielli AF. Emodepside - A Promising Drug for the Treatment of Soil-Transmitted Helminthiases. N Engl J Med. 2023 May 18;388(20):1907-1908. doi: 10.1056/NEJMe2303793. No abstract available.
PubMed 37195949Mrimi EC, Welsche S, Ali SM, Hattendorf J, Keiser J. Emodepside for Trichuris trichiura and Hookworm Infection. N Engl J Med. 2023 May 18;388(20):1863-1875. doi: 10.1056/NEJMoa2212825.
PubMed 37195942
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm: Randomized Two Stages Phase II Seamless Adaptive Controlled Single-blind Trials
- ClinicalTrials.gov ID
- NCT05017194
- Acronym / sponsor ID
- EMODEP_PEMBA / EMODEP_PEMBA
- Keywords
- Emodepside, Trichuris trichiura, Hookworm, Soil-transmitted helminths, Efficacy, Safety, Dose selection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Jennifer KeiserUniversity, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 23 Aug 2021 (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 rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Emodepside 5 mg | Experimental | Drug: Emodepside |
| Emodepside 10 mg | Experimental | Drug: Emodepside |
| Emodepside 15 mg | Experimental | Drug: Emodepside |
| Emodepside 20 mg | Experimental | Drug: Emodepside |
| Emodepside 25 mg | Experimental | Drug: Emodepside |
| Emodepside 30 mg | Experimental | Drug: Emodepside |
| Albendazole | Active comparator | Drug: Emodepside |
| Placebo | Placebo comparator | Drug: Emodepside |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female adults aged between 18 and 45 years
- Written and signed informed consent
- Examined by a study physician before treatment
- Provided two stool samples at baseline
- Trichuris trichiura and hookworm EPG ≥ 48 and at least two Kato-Katz thick smears slides with more than one Trichuris trichiura and hookworm eggs
Key exclusion criteria (10 listed)
- Pregnant or lactating and/or planning to become pregnant within three months after drug treatment
- Type 1 and/or 2 diabetes
- Psychiatric disorders
- History of ophthalmological conditions
- Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, during initial clinical assessment
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 ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo. | Drug | Albendazole, Emodepside 10 mg, Emodepside 15 mg, Emodepside 20 mg, Emodepside 25 mg, Emodepside 30 mg, Emodepside 5 mg, Placebo |
Primary outcome
Cure rate (CR) of emodepside against Trichuris trichiura
Time frame: In the week between 14 and 21 days post-treatment
CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment.
Cure rate (CR) of emodepside against hookworm
Time frame: In the week between 14 and 21 days post-treatment
CR will be calculated as the percentage of hookworm egg-positive participants at baseline who become egg-negative after treatment.
3 secondary outcomes
Geometric Mean Egg Reduction Rate (ERR) of the emodepside against Trichuris trichiura and hookworm.
Time frame: In the week between 14 and 21 days post-treatment
CR against Ascaris lumbricoides
Time frame: In the week between 14 and 21 days post-treatment
ERR against Ascaris lumbricoides
Time frame: In the week between 14 and 21 days post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Derived from this study: PubMed 37195949Montresor A, Gabrielli AF. Emodepside - A Promising Drug for the Treatment of Soil-Transmitted Helminthiases. N Engl J Med. 2023 May 18;388(20):1907-1908. doi: 10.1056/NEJMe2303793. No abstract available.
- Derived from this study: PubMed 37195942Mrimi EC, Welsche S, Ali SM, Hattendorf J, Keiser J. Emodepside for Trichuris trichiura and Hookworm Infection. N Engl J Med. 2023 May 18;388(20):1863-1875. doi: 10.1056/NEJMoa2212825.
- Individual participant dataSharing planned: No
Related trials for Trichuris Trichiura; Infection
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Not yet recruitingPhase 3
Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections
Trichuris Trichiura; Infection, Hookworm Infection
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Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras
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Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Emodepside in people with Trichuris Trichiura; Infection and Hookworm Infections, run by Jennifer Keiser at 1 site in Tanzania.
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 10 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: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 against Trichuris trichiura (time frame: In the week between 14 and 21 days post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05017194, which also lists 2 linked publications.
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 27 May 2022.