NCT05017194

Brief Summary

The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
442

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

August 2, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 23, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

July 5, 2021

Last Update Submit

May 26, 2022

Conditions

Trichuris Trichiura; InfectionHookworm Infections

Keywords

EmodepsideTrichuris trichiuraHookwormSoil-transmitted helminthsEfficacySafetyDose selection

Outcome Measures

Primary Outcomes (2)

  • Cure rate (CR) of emodepside against Trichuris trichiura

    CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment.

    In the week between 14 and 21 days post-treatment

  • 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 (3)

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

    In the week between 14 and 21 days post-treatment

  • CR against Ascaris lumbricoides

    In the week between 14 and 21 days post-treatment

  • ERR against Ascaris lumbricoides

    In the week between 14 and 21 days post-treatment

Study Arms (8)

Emodepside 5 mg

EXPERIMENTAL
Drug: Emodepside

Emodepside 10 mg

EXPERIMENTAL
Drug: Emodepside

Emodepside 15 mg

EXPERIMENTAL
Drug: Emodepside

Emodepside 20 mg

EXPERIMENTAL
Drug: Emodepside

Emodepside 25 mg

EXPERIMENTAL
Drug: Emodepside

Emodepside 30 mg

EXPERIMENTAL
Drug: Emodepside

Albendazole

ACTIVE COMPARATOR
Drug: Emodepside

Placebo

PLACEBO COMPARATOR
Drug: Emodepside

Interventions

EmodepsideDRUG

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.

AlbendazoleEmodepside 10 mgEmodepside 15 mgEmodepside 20 mgEmodepside 25 mgEmodepside 30 mgEmodepside 5 mgPlacebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female adults aged between 18 and 45 years
  • Written and signed informed consent
  • Examined by a study physician before treatment
  • Provided two stool samples at baseline
  • Trichuris trichiura and hookworm EPG ≥ 48 and at least two Kato-Katz thick smears slides with more than one Trichuris trichiura and 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Laboratory - Ivo de Carneri

Chake Chake, 122, Tanzania

Location

Related Publications (2)

  • Montresor A, Gabrielli AF. Emodepside - A Promising Drug for the Treatment of Soil-Transmitted Helminthiases. N Engl J Med. 2023 May 18;388(20):1907-1908. doi: 10.1056/NEJMe2303793. No abstract available.

    PMID: 37195949DERIVED

  • Mrimi EC, Welsche S, Ali SM, Hattendorf J, Keiser J. Emodepside for Trichuris trichiura and Hookworm Infection. N Engl J Med. 2023 May 18;388(20):1863-1875. doi: 10.1056/NEJMoa2212825.

    PMID: 37195942DERIVED

MeSH Terms

Conditions

TrichuriasisHookworm InfectionsAncylostomiasis

Interventions

emodepside

Condition Hierarchy (Ancestors)

Enoplida InfectionsAdenophorea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfectionsStrongylida InfectionsSecernentea Infections

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

July 5, 2021

First Posted

August 23, 2021

Study Start

August 2, 2021

Primary Completion

December 10, 2021

Study Completion

December 10, 2021

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

TA(1)