Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis (NCT06373835) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis
Laos202 participantsStarted 2024-05-20
Plain-language 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
Who can participate
Age range18 Years – 60 Years
SexALL
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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 CY…
What they're measuring
1
Cure rate (CR) of emodepside against Strongyloides stercoralis
Timeframe: In the week between 14 and 21 days post-treatment