Efficacy and Safety of Emodepside in Adults Infected With Hookworm

• Status: Not yet recruiting
• Trial end date: 2022-12-12
• Target enrollment: 0
• Participant gender: All

Summary

To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 18-60, inclusive, infected with hookworm.

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

Details

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

Criteria

Inclusion Criteria:

• Male or female adults aged between 18 and 60 years;

• Written and signed informed consent;

• Was examined by a study physician before treatment;

• Provided two stool samples at baseline;

• Hookworm EPG > 48 and at least two Kato-Katz thick smears slides with more than one 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.

• Participated in stage I trials of this protocol