Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis

NCT ID: NCT06373835

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-20
• Study Completion Date: 2024-09-21

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

Conditions

Strongyloides Stercoralis Infection; Strongyloidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Emodepside 5 mg

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Group Type: EXPERIMENTAL

Emodepside

Intervention Type: DRUG

5 mg tablets of emodepside and matching placebo tablets, 3mg ivermectin

Emodepside 10 mg

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Group Type: EXPERIMENTAL

Emodepside

Intervention Type: DRUG

5 mg tablets of emodepside and matching placebo tablets, 3mg ivermectin

Emodepside 15 mg

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Group Type: EXPERIMENTAL

Emodepside

Intervention Type: DRUG

5 mg tablets of emodepside and matching placebo tablets, 3mg ivermectin

Emodepside 20 mg

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Group Type: EXPERIMENTAL

Emodepside

Intervention Type: DRUG

5 mg tablets of emodepside and matching placebo tablets, 3mg ivermectin

Emodepside 25 mg

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Group Type: EXPERIMENTAL

Emodepside

Intervention Type: DRUG

5 mg tablets of emodepside and matching placebo tablets, 3mg ivermectin

Emodepside 30 mg

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Group Type: EXPERIMENTAL

Emodepside

Intervention Type: DRUG

5 mg tablets of emodepside and matching placebo tablets, 3mg ivermectin

Placebo

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Group Type: PLACEBO_COMPARATOR

Emodepside

Intervention Type: DRUG

5 mg tablets of emodepside and matching placebo tablets, 3mg ivermectin

Ivermectin 3 mg

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.

Group Type: ACTIVE_COMPARATOR

Emodepside

Intervention Type: DRUG

5 mg tablets of emodepside and matching placebo tablets, 3mg ivermectin

Interventions

Emodepside

5 mg tablets of emodepside and matching placebo tablets, 3mg ivermectin

Intervention Type: DRUG

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Public Health, Vientiane, Laos

OTHER

Sponsor Role: collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lao Tropical and Public Health Institute

Vientiane, , Laos

Countries

Laos

References

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 Jun 25:S1473-3099(25)00255-5. doi: 10.1016/S1473-3099(25)00255-5. Online ahead of print.

Reference Type: DERIVED

PMID: 40580974 (View on PubMed)

Other Identifiers

EMODEPSIDE_LAOS

Identifier Type: -

Identifier Source: org_study_id