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

Jennifer Keiser

Status and phase: Not yet enrolling; Phase 2

Conditions: Trichuris; Trichuris Infection

Treatments: Drug: Albendazole 400 mg; Drug: Emodepside

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07258173

EMODEPSIDE_CÔTE_D'IVOIRE

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Emodepside 15mg

Experimental group

Treatment:

Drug: Emodepside

Albendazole 400 mg

Active Comparator group

Treatment:

Drug: Albendazole 400 mg