Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm

• Status: Recruiting
• Trial end date: 2021-10-19
• Target enrollment: 0
• Participant gender: All

Summary

The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jennifer Keiser
• Collaborator: Public Health Laboratory Ivo de Carneri
• Treatments: Emodepside

Criteria

Inclusion Criteria:

• Male or female adults aged between 18 and 45 years

• Written and signed informed consent

• Examined by a study physician before treatment

• Provided two stool samples at baseline

• Trichuris trichiura and hookworm EPG > 48 and at least two Kato-Katz thick smears slides with more than one Trichuris trichiura and hookworm eggs

Exclusion Criteria:

• Pregnant or lactating and/or planning to become pregnant within three months after drug treatment

• Type 1 and/or 2 diabetes

• Psychiatric disorders

• History of ophthalmological conditions

• Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, during initial clinical assessment

• Suffers from severe anaemia (Hb < 80 g/l)

• Received anthelminthic treatment within past four weeks

• Attending other clinical trials during the study

• Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin

• Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir