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

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

Study Overview

• Status: Completed
• Conditions: Hookworm Infections
• Intervention / Treatment: Drug: Emodepside; Drug: Albendazole 400mg

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Phase 2

Contacts and Locations

Study Locations

• Tanzania
  • Pemba
    • Chake Chake, Pemba, Tanzania, 122
      • Public Health Laboratory Ivo de Carneri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emodepside 30 mg	Drug: Emodepside; Treatment with Emodepside 30 mg
Active Comparator: Albendazole 400 mg	Drug: Albendazole 400mg; Treatment with Albendazole 400 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure rate (CR) of emodepside against hookworm	CR will be calculated as the percentage of hookworm egg-positive participants at baseline who become egg-negative after treatment.	In the week between 14 and 21 days post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Egg Reduction Rate (ERR) of the emodepside against hookworm.	Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100).	In the week between 14 and 21 days post-treatment
CR of emodepside against Trichuris trichiura and Ascaris lumbricoides	CR will be calculated as the percentage of Trichuris trichiura and Ascaris lumbricoides egg-positive participants at baseline who become egg-negative after treatment.	In the week between 14 and 21 days post-treatment
ERR of the emodepside against Trichuris trichiura and Ascaris lumbricoides.	EPG will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The ERR is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100).	In the week between 14 and 21 days post-treatment
Infection status and intensity assessed for at baseline and 14-21 days post-treatment by FECPAK-G2.		At baseline and 14-21 days post-treatment

Collaborators and Investigators

• Sponsor: Jennifer Keiser
• Collaborators: Public Health Laboratory Ivo de Carneri

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2022
• Primary Completion (Actual): April 11, 2023
• Study Completion (Actual): April 11, 2023

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Hookworm; Emodepside; Confirmatory Stage; Soil Transmitted Helminth
• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Secernentea Infections; Nematode Infections; Helminthiasis; Strongylida Infections; Hookworm Infections; Ancylostomiasis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antiprotozoal Agents; Antiparasitic Agents; Anthelmintics; Antiplatyhelmintic Agents; Anticestodal Agents; Albendazole; Emodepside
• Other Study ID Numbers: EMODEPSIDE_PEMBA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No