Efficacy and Safety of a Single Dose of Emodepside Compared to a Single Dose of Albendazole in Adolescents and Adults Infected With Trichuris Incognita

Efficacy and Safety of a Single Dose of Emodepside Compared to a Single Dose of Albendazole in Adolescents and Adults Infected With Trichuris Incognita: a Phase II, Randomized, Double Blind, Controlled Trial

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.

Inclusion Criteria:

• Aged 12 years and above.
• Written informed consent signed by participant and, in the case of minors, parents/caregivers.
• Agree to comply with study procedures, including provision of two stool samples at the beginning (screening) and at follow-up assessment 14-21 days after treatment.
• Having at least two slides of the quadruple Kato-Katz thick smears positive for Trichuris incognita and infection intensities of at least 48 eggs per gram (EPG).
• Willing to be examined by a study physician prior to treatment.

Exclusion Criteria:

• Presence or signs of major systemic illnesses, e.g. body temperature ≥ 38 °C, severe anemia (Hb below 80g/l) upon initial clinical assessment etc.
• History of severe acute or unmanaged severe chronic disease (i.e., condition is not as therapeutically controlled as necessary).
• Positive malaria rapid diagnostic test (RDT) and temperature ≥ 38 °C.
• Abnormal liver and renal function assessed by biochemical blood-based analyses.
• Recent use of anthelmintic drugs (in the 4 weeks before treatment).
• Known allergy to study medications and formulations (i.e. albendazole and emodepside).
• Prescribed or taking medication with known contraindication to or interaction with study drugs.
• Participating in other clinical trials during the study period.
• Pregnancy or breastfeeding.