Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm

Jennifer Keiser

Status and phase

Completed

Phase 2

Conditions

Hookworm Infections

Treatments

Drug: Emodepside

Drug: Albendazole 400mg

Study type

Interventional

Funder types

Other

Identifiers

EMODEPSIDE_PEMBA

Details and patient eligibility

About

To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 12-60, inclusive, infected with hookworm.

Enrollment

320 patients

Sex

All

Ages

12 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female adults aged between 12 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