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
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