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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
202
5 mg tablets of emodepside and matching placebo tablets, 3mg ivermectin
Lao Tropical and Public Health Institute
Vientiane, Laos
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.
Time frame: In the week between 14 and 21 days post-treatment
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.
Time frame: Actively evaluated at 3 hours, 24 hours, 72 hours, and 14 days post-treatment
Geometric Mean Larvae Reduction Rate (LRR) of emodepside against Strongyloides stercoralis.
The LRRs will be calculated based on the geometric mean
Time frame: In the week between 14 and 21 days post-treatment
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.
Time frame: Actively collected at 0 hours, 0.5 hours, 2.5 hours, 5 hours, 24 hours, 72 hours, and 14 days post-treatment
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).
Time frame: In the week between 14 and 21 days post-treatment
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