Clinical trial NCT06373835: Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Strongyloides Stercoralis Infection
Strongyloidiasis
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Public Health, Vientiane, Laos
First posted: 2024-04-18
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Cure rate (CR) of emodepside against Strongyloides stercoralis
timeFrame: In the week between 14 and 21 days post-treatment
Secondary outcomes:
measure: Safety and tolerability of the dose-dependent emodepside treatment regimes, and compared with ivermectin.
timeFrame: Actively evaluated at 3 hours, 24 hours, 72 hours, and 14 days post-treatment
measure: Geometric Mean Larvae Reduction Rate (LRR) of emodepside against Strongyloides stercoralis.
timeFrame: In the week between 14 and 21 days post-treatment
measure: Exposure response of emodepside in adults
timeFrame: Actively collected at 0 hours, 0.5 hours, 2.5 hours, 5 hours, 24 hours, 72 hours, and 14 days post-treatment
measure: Cure rate (CR) and egg reduction rate (ERR) with other soil-transmitted helminths (STH) and trematodes
timeFrame: In the week between 14 and 21 days post-treatment
Other outcomes:
Locations:
city: Vientiane
country: Lao People's Democratic Republic
facility: Lao Tropical and Public Health Institute
Study officials:
References: