The purpose of this clinical trial is to compare the efficacy and safety of emodepside, with the standard treatment, albendazole, in adolescents (12 years and older) and adults infected with Trichuris incognita.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Treatment with 15 mg of emodepside
Treatment with 400mg of albendazole
Cure rate (CR) of emodepside compared to albendazole against Trichuris incognita
Trichuris incognita infection status of participants 14-21 days post-treatment assessed by Kato-Katz. CRs will be calculated as the percentage of egg-positive participants at screening who become egg-negative after treatment, for each treatment arm. Differences in CRs between the two treatments will be assessed.
Time frame: Between 14-21 days post-treatment
Egg-reduction rate (ERR) of emodepside compared to albendazole against Trichuris incognita
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. ERR is caluclated as follows: ERR = (1- (geometric mean EPG at follow-up ÷ geometric mean EPG at baseline)) x 100
Time frame: Between 14-21 days post-treatment
Safety and tolerability
Tolerability of treatments (adverse events (AEs)) will be assessed at 3- and 24- hours post-treatment and at 14 - 21 days follow up. The safety analysis will be conducted on all participants who were treated and include all available drug safety data. AEs will be evaluated descriptively as the difference between proportions of reported AEs before and after treatment.
Time frame: 3- and 24- hours post-treatment and retrospectively 14-21 days post-treatment
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