Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis

Strongyloidiasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06373835
• Other study ID #: EMODEPSIDE_LAOS
• Status: Recruiting
• Phase: Phase 2
• Start date: May 20, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: Swiss Tropical & Public Health Institute
• Contact: Jennifer Keiser, PhD
• Phone: +41 61 284 81 11
• Email: jennifer.keiser[@]swisstph.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Strongyloides Stercoralis Infection
• Strongyloidiasis

Intervention

Drug:
• Emodepside
5 mg tablets of emodepside and matching placebo tablets, 3mg ivermectin

Locations

Country	Name	City	State
Lao People's Democratic Republic	Lao Tropical and Public Health Institute	Vientiane

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	National Institute of Public Health, Vientiane, Laos

Country where clinical trial is conducted

Lao People's Democratic Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	In the week between 14 and 21 days post-treatment
Secondary	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.	Actively evaluated at 3 hours, 24 hours, 72 hours, and 14 days post-treatment
Secondary	Geometric Mean Larvae Reduction Rate (LRR) of emodepside against Strongyloides stercoralis.	The LRRs will be calculated based on the geometric mean	In the week between 14 and 21 days post-treatment
Secondary	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.	Actively collected at 0 hours, 0.5 hours, 2.5 hours, 5 hours, 24 hours, 72 hours, and 14 days post-treatment
Secondary	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).	In the week between 14 and 21 days post-treatment