Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis

Phase 2

Completed

• Conditions: Strongyloidiasis; Strongyloides Stercoralis Infection
• Interventions: Drug: Emodepside

• Registration Number: NCT06373835
• Lead Sponsor: Swiss Tropical & Public Health Institute

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-18
• Study Start: 2024-05-20
• Primary Completion: 2024-09-21
• Study Completion: 2024-09-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emodepside 15 mg	Emodepside	Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.
Placebo	Emodepside	Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.
Emodepside 5 mg	Emodepside	Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.
Emodepside 10 mg	Emodepside	Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.
Emodepside 20 mg	Emodepside	Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.
Emodepside 25 mg	Emodepside	Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.
Emodepside 30 mg	Emodepside	Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.
Ivermectin 3 mg	Emodepside	Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Primary Outcome Measures

Name	Time	Method
Cure rate (CR) of emodepside against Strongyloides stercoralis	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.

Secondary Outcome Measures

Name	Time	Method
Cure rate (CR) and egg reduction rate (ERR) with other soil-transmitted helminths (STH) and trematodes	In the week between 14 and 21 days post-treatment	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).
Geometric Mean Larvae Reduction Rate (LRR) of emodepside against Strongyloides stercoralis.	In the week between 14 and 21 days post-treatment	The LRRs will be calculated based on the geometric mean
Safety and tolerability of the dose-dependent emodepside treatment regimes, and compared with ivermectin.	Actively evaluated at 3 hours, 24 hours, 72 hours, and 14 days post-treatment	AEs will be evaluated descriptively as the difference of proportion reported AEs before and after treatment.
Exposure response of emodepside in adults	Actively collected at 0 hours, 0.5 hours, 2.5 hours, 5 hours, 24 hours, 72 hours, and 14 days post-treatment	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.

Trial Locations

Locations (1)

Lao Tropical and Public Health Institute; 🇱🇦 Vientiane, Lao People's Democratic Republic