Strongyloides Stercoralis Infection, Strongyloidiasis
Conditions
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
Interventions
DRUGEmodepside
5 mg tablets of emodepside and matching placebo tablets, 3mg ivermectin
Sponsors
National Institute of Public Health, Vientiane, Laos
Swiss Tropical & Public Health Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate (CR) of emodepside against Strongyloides stercoralis | In the week between 14 and 21 days post-treatment | The CR will be calculated as the proportion of Strongyloides stercoralis larvae-positive participants at baseline who become larvae-negative after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of the dose-dependent emodepside treatment regimes, and compared with ivermectin. | Actively evaluated at 3 hours, 24 hours, 72 hours, and 14 days post-treatment | AEs will be evaluated descriptively as the difference of proportion reported AEs before and after treatment. |
| Geometric Mean Larvae Reduction Rate (LRR) of emodepside against Strongyloides stercoralis. | In the week between 14 and 21 days post-treatment | The LRRs will be calculated based on the geometric mean |
| Exposure response of emodepside in adults | Actively collected at 0 hours, 0.5 hours, 2.5 hours, 5 hours, 24 hours, 72 hours, and 14 days post-treatment | 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. |
| Cure rate (CR) and egg reduction rate (ERR) with other soil-transmitted helminths (STH) and trematodes | In the week between 14 and 21 days post-treatment | 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). |
Countries
Laos
Outcome results
None listed