Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis

Swiss Tropical and Public Health (TPH) Institute

Status and phase: Completed; Phase 2

Conditions: Strongyloidiasis; Strongyloides Stercoralis Infection

Treatments: Drug: Emodepside

Study type: Interventional

Funder types: Other

Identifiers

NCT06373835

EMODEPSIDE_LAOS

Details and patient eligibility

About

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

Enrollment: 202 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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202 participants in 8 patient groups, including a placebo group

Emodepside 5 mg

Experimental group

Description:

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

Treatment:

Drug: Emodepside

Emodepside 10 mg

Experimental group

Description:

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

Treatment:

Drug: Emodepside

Emodepside 15 mg

Experimental group

Description:

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

Treatment:

Drug: Emodepside

Emodepside 20 mg

Experimental group

Description:

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

Treatment:

Drug: Emodepside

Emodepside 25 mg

Experimental group

Description:

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

Treatment:

Drug: Emodepside

Emodepside 30 mg

Experimental group

Description:

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

Treatment:

Drug: Emodepside

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Emodepside

Ivermectin 3 mg

Active Comparator group

Description:

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

Treatment:

Drug: Emodepside