Strongyloides Stercoralis InfectionPhase 2NCT06373835
Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis
A Phase 2 study testing Emodepside in people with Strongyloides Stercoralis Infection and Strongyloidiasis, run by Swiss Tropical & Public Health Institute at 1 site in Laos.
Trial summary
Efficacy, safety and pharmacokinetics of ascending dosages of emodepside and in comparison to ivermectin against Strongyloidiasis stercoralis in adults: randomized stage II seamless adaptive controlled trials Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Strongyloides Stercoralis Infection, Strongyloidiasis
- What is being tested?
- Emodepside
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteLaos
- Study dates
- 20 May 2024to 21 Sep 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent signed by the participant him/herself
- Males and females of age 18 or older
- Infected with S. stercoralis (positive by at least two Baermann assays on two different days and infection intensities of at least 0.75 LPG in the two stool samples.
- Agree to comply with the study procedures, including to be examined by a study physician at the beginning of the study and to provide three stool samples during the screening period (within a maximum of 10 days) and approximately three weeks after treatment (follow-up).
- Female participants of childbearing potential to ensure adequate contraception during the study period.
Who cannot join
- No written informed consent by individual.
- Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment.
- Recent history of acute or severe chronic disease, as assessed by a medical doctor or reported by the participant: Type 1 and/or 2 diabetes; Psychiatric disorders; Chronic heart, liver, or renal disease
- Prior treatment with anthelmintics (eg, diethylcarbamazine [DEC], suramin, ivermectin, mebendazole or albendazole) within 4 weeks before planned study drug administration.
- Actively participating in other clinical trials during the study.
- Positive pregnancy test or breastfeeding women and planning to become pregnant within three months of study drug administration.
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- Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin within 4 weeks before planned study drug administration.
- Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir.
- Known allergy to study drugs or any of the ingredients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy, Safety and Pharmacokinetics of Ascending Dosages of Emodepside and in Comparison to Ivermectin Against Strongyloidiasis Stercoralis in Adults: Randomized Stage II Seamless Adaptive Controlled Trials
Efficacy, safety and pharmacokinetics of ascending dosages of emodepside and in comparison to ivermectin against Strongyloidiasis stercoralis in adults: randomized stage II seamless adaptive controlled trials
- Being tested
- Emodepside
- Medical subject headings
- Strongyloidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmodepsideDrug
5 mg tablets of emodepside and matching placebo tablets, 3mg ivermectin
| Study group | Role | What they receive |
|---|---|---|
| Emodepside 5 mg | Experimental | Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. Receives: Drug: Emodepside |
| Emodepside 10 mg | Experimental | Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. Receives: Drug: Emodepside |
| Emodepside 15 mg | Experimental | Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. Receives: Drug: Emodepside |
| Emodepside 20 mg | Experimental | Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. Receives: Drug: Emodepside |
| Emodepside 25 mg | Experimental | Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. Receives: Drug: Emodepside |
| Emodepside 30 mg | Experimental | Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. Receives: Drug: Emodepside |
| Placebo | Placebo comparator | Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. Receives: Drug: Emodepside |
| Ivermectin 3 mg | Active comparator | Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. 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 Strongyloides stercoralis
The CR will be calculated as the proportion of Strongyloides stercoralis larvae-positive participants at baseline who become larvae-negative after treatment.
Measured: In the week between 14 and 21 days post-treatment
Secondary outcomes (4)
Safety and tolerability of the dose-dependent emodepside treatment regimes, and compared with ivermectin.
AEs will be evaluated descriptively as the difference of proportion reported AEs before and after treatment.
Measured: Actively evaluated at 3 hours, 24 hours, 72 hours, and 14 days post-treatment
Geometric Mean Larvae Reduction Rate (LRR) of emodepside against Strongyloides stercoralis.
The LRRs will be calculated based on the geometric mean
Measured: In the week between 14 and 21 days post-treatment
Exposure response of emodepside in adults
Emodepside will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml.
Measured: Actively collected at 0 hours, 0.5 hours, 2.5 hours, 5 hours, 24 hours, 72 hours, and 14 days post-treatment
Cure rate (CR) and egg reduction rate (ERR) with other soil-transmitted helminths (STH) and trematodes
The CR will be calculated as the proportion of the STH or trematode positive participants at baseline who become egg-negative after treatment. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG 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 posted18 Apr 2024
- Study start20 May 2024
- Primary completion21 Sep 2024
- Study completion21 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Strongyloides Stercoralis 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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Public Health, Vientiane, Laos
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373835
- Sponsor's protocol ID
- EMODEPSIDE_LAOS
- Status last verified
- Oct 2024
- First submitted
- 16 Apr 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taylor L, Many S, Jeanguenat H, Hattendorf J, Sayasone S, Keiser J. Efficacy and safety of ascending doses of emodepside in comparison with ivermectin in adults infected with Strongyloides stercoralis in Laos: a phase 2a, dose-ranging, randomised, parallel-group, placebo-controlled, single-blind clinical trial. Lancet Infect Dis. 2025 Nov;25(11):1254-1264. doi: 10.1016/S1473-3099(25)00255-5. Epub 2025 Jun 25.
PubMed 40580974
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Pharmacokinetics of Ascending Dosages of Emodepside and in Comparison to Ivermectin Against Strongyloidiasis Stercoralis in Adults: Randomized Stage II Seamless Adaptive Controlled Trials
- ClinicalTrials.gov ID
- NCT06373835
- Acronym / sponsor ID
- EMODEPSIDE_LAOS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- National Institute of Public Health, Vientiane, Laos
- Study start
- 20 May 2024 (actual)
- Primary completion
- 21 Sep 2024 (actual)
- Study completion
- 21 Sep 2024 (actual)
- First posted
- 18 Apr 2024 (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.
Efficacy, safety and pharmacokinetics of ascending dosages of emodepside and in comparison to ivermectin against Strongyloidiasis stercoralis in adults: randomized stage II seamless adaptive controlled trials
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: EmodepsideTreatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. |
| Emodepside 10 mg | Experimental | Drug: EmodepsideTreatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. |
| Emodepside 15 mg | Experimental | Drug: EmodepsideTreatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. |
| Emodepside 20 mg | Experimental | Drug: EmodepsideTreatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. |
| Emodepside 25 mg | Experimental | Drug: EmodepsideTreatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. |
| Emodepside 30 mg | Experimental | Drug: EmodepsideTreatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. |
| Placebo | Placebo comparator | Drug: EmodepsideTreatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. |
| Ivermectin 3 mg | Active comparator | Drug: EmodepsideTreatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Written informed consent signed by the participant him/herself
- Males and females of age 18 or older
- Infected with S. stercoralis (positive by at least two Baermann assays on two different days and infection intensities of at least 0.75 LPG in the two stool samples.
- Agree to comply with the study procedures, including to be examined by a study physician at the beginning of the study and to provide three stool samples during the screening period (within a maximum of 10 days) and approximately three weeks after treatment (follow-up).
- Female participants of childbearing potential to ensure adequate contraception during the study period.
Key exclusion criteria (9 listed)
- No written informed consent by individual.
- Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment.
- Recent history of acute or severe chronic disease, as assessed by a medical doctor or reported by the participant: Type 1 and/or 2 diabetes; Psychiatric disorders; Chronic heart, liver, or renal disease
- Prior treatment with anthelmintics (eg, diethylcarbamazine [DEC], suramin, ivermectin, mebendazole or albendazole) within 4 weeks before planned study drug administration.
- Actively participating in other clinical trials during the study.
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 |
|---|---|---|
| Emodepside5 mg tablets of emodepside and matching placebo tablets, 3mg ivermectin | Drug | Emodepside 10 mg, Emodepside 15 mg, Emodepside 20 mg, Emodepside 25 mg, Emodepside 30 mg, Emodepside 5 mg, Ivermectin 3 mg, Placebo |
Primary outcome
Cure rate (CR) of emodepside against Strongyloides stercoralis
Time frame: In the week between 14 and 21 days post-treatment
The CR will be calculated as the proportion of Strongyloides stercoralis larvae-positive participants at baseline who become larvae-negative after treatment.
4 secondary outcomes
Safety and tolerability of the dose-dependent emodepside treatment regimes, and compared with ivermectin.
Time frame: Actively evaluated at 3 hours, 24 hours, 72 hours, and 14 days post-treatment
Geometric Mean Larvae Reduction Rate (LRR) of emodepside against Strongyloides stercoralis.
Time frame: In the week between 14 and 21 days post-treatment
Exposure response of emodepside in adults
Time frame: Actively collected at 0 hours, 0.5 hours, 2.5 hours, 5 hours, 24 hours, 72 hours, and 14 days post-treatment
Cure rate (CR) and egg reduction rate (ERR) with other soil-transmitted helminths (STH) and trematodes
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 20 Nov 2024.
- Derived from this study: PubMed 40580974Taylor L, Many S, Jeanguenat H, Hattendorf J, Sayasone S, Keiser J. Efficacy and safety of ascending doses of emodepside in comparison with ivermectin in adults infected with Strongyloides stercoralis in Laos: a phase 2a, dose-ranging, randomised, parallel-group, placebo-controlled, single-blind clinical trial. Lancet Infect Dis. 2025 Nov;25(11):1254-1264. doi: 10.1016/S1473-3099(25)00255-5. Epub 2025 Jun 25.
- Individual participant dataSharing planned: No
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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 Strongyloides Stercoralis Infection and Strongyloidiasis, run by Swiss Tropical & Public Health Institute at 1 site in Laos.
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: finished, as of the sponsor's last update on 20 Nov 2024. 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 Laos. 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 Strongyloides stercoralis (time frame: In the week between 14 and 21 days post-treatment). 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 NCT06373835, which also lists 1 linked publication.
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 20 Nov 2024.