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COMPLETEDPHASE2

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

Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Trichuris Trichiura and Hookworm: Randomized Two Stages Phase II Seamless Adaptive Controlled Single-blind Trials

NCT05538767•Jennifer Keiser

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

12 - 60 years

Sex

ALL

Healthy Volunteers

Yes

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.
+1 more criteria

Locations (1)

Public Health Laboratory Ivo de Carneri

Chake Chake, Pemba, Tanzania

Key Dates

Start Date

September 16, 2022

Primary Completion Date

April 11, 2023

Completion Date

April 11, 2023

Last Updated

June 15, 2023

Enrollment

320

ACTUAL participants

Conditions

Hookworm Infections

Interventions

Emodepside

DRUG

Albendazole 400mg

DRUG

Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm

NCT03995680

Hookworm Infections

View study

UNKNOWNNA

Soil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education

NCT04227834

HelminthiasisAscaris Infection+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm

Soil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education

Mebendazole Study Against Hookworm Infections in Children and Adolescents in Ghana