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

NCT05538767 | Completed Phase 2

• 1 other identifier: EMODEPSIDE_PEMBA
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hookworm Infections

Keywords

Hookworm; Emodepside; Efficacy; Safety; Confirmatory Stage; Soil Transmitted Helminth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Geometric Mean Egg Reduction Rate (ERR) of the emodepside against hookworm.

  In the week between 14 and 21 days post-treatment

• CR of emodepside against Trichuris trichiura and Ascaris lumbricoides

  In the week between 14 and 21 days post-treatment

• ERR of the emodepside against Trichuris trichiura and Ascaris lumbricoides.

  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

Study Arms (2)

Emodepside 30 mg

EXPERIMENTAL

Drug: Emodepside

Albendazole 400 mg

ACTIVE COMPARATOR

Drug: Albendazole 400mg

Interventions

Emodepside DRUG

Treatment with Emodepside 30 mg

Emodepside 30 mg

Albendazole 400mg DRUG

Treatment with Albendazole 400 mg

Albendazole 400 mg

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jennifer Keiser: lead
• Public Health Laboratory Ivo de Carneri: collaborator

Study Sites (1)

Public Health Laboratory Ivo de Carneri

Chake Chake, Pemba, 122, Tanzania

Location

Related Publications (1)

• Taylor L, Ahmada AA, Ali MS, Ali SM, Hattendorf J, Mohammed IS, Keiser J. Efficacy and safety of emodepside compared with albendazole in adolescents and adults with hookworm infection in Pemba Island, Tanzania: a double-blind, superiority, phase 2b, randomised controlled trial. Lancet. 2024 Aug 17;404(10453):683-691. doi: 10.1016/S0140-6736(24)01403-X.

  PMID: 39153818 DERIVED

MeSH Terms

Conditions

Hookworm Infections; Ancylostomiasis

Interventions

emodepside; Albendazole

Condition Hierarchy (Ancestors)

Strongylida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 14, 2022
• Study Start: September 16, 2022
• Primary Completion: April 11, 2023
• Study Completion: April 11, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

TA (1)