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Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm (EMODEP_PEMBA)

Primary Purpose

Trichuris Trichiura; Infection, Hookworm Infections

Status
Completed
Phase
Phase 2
Locations
Tanzania
Study Type
Interventional
Intervention
Emodepside
Sponsored by
Jennifer Keiser
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trichuris Trichiura; Infection focused on measuring Emodepside, Trichuris trichiura, Hookworm, Soil-transmitted helminths, Efficacy, Safety, Dose selection

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

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

Sites / Locations

  • Public Health Laboratory - Ivo de Carneri

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Emodepside 5 mg

Emodepside 10 mg

Emodepside 15 mg

Emodepside 20 mg

Emodepside 25 mg

Emodepside 30 mg

Albendazole

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Geometric Mean Egg Reduction Rate (ERR) of the emodepside against Trichuris trichiura and 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).
CR against Ascaris lumbricoides
CR will be calculated as the percentage of Ascaris lumbricoides egg-positive participants at baseline who become egg-negative after treatment.
ERR against Ascaris lumbricoides
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).

Full Information

First Posted
July 5, 2021
Last Updated
May 26, 2022
Sponsor
Jennifer Keiser
Collaborators
Public Health Laboratory Ivo de Carneri
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1. Study Identification

Unique Protocol Identification Number
NCT05017194
Brief Title
Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm
Acronym
EMODEP_PEMBA
Official Title
Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm: Randomized Two Stages Phase II Seamless Adaptive Controlled Single-blind Trials
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
December 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jennifer Keiser
Collaborators
Public Health Laboratory Ivo de Carneri

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichuris Trichiura; Infection, Hookworm Infections
Keywords
Emodepside, Trichuris trichiura, Hookworm, Soil-transmitted helminths, Efficacy, Safety, Dose selection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
442 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emodepside 5 mg
Arm Type
Experimental
Arm Title
Emodepside 10 mg
Arm Type
Experimental
Arm Title
Emodepside 15 mg
Arm Type
Experimental
Arm Title
Emodepside 20 mg
Arm Type
Experimental
Arm Title
Emodepside 25 mg
Arm Type
Experimental
Arm Title
Emodepside 30 mg
Arm Type
Experimental
Arm Title
Albendazole
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Emodepside
Intervention Description
Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.
Primary Outcome Measure Information:
Title
Cure rate (CR) of emodepside against Trichuris trichiura
Description
CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment.
Time Frame
In the week between 14 and 21 days post-treatment
Title
Cure rate (CR) of emodepside against hookworm
Description
CR will be calculated as the percentage of hookworm egg-positive participants at baseline who become egg-negative after treatment.
Time Frame
In the week between 14 and 21 days post-treatment
Secondary Outcome Measure Information:
Title
Geometric Mean Egg Reduction Rate (ERR) of the emodepside against Trichuris trichiura and hookworm.
Description
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).
Time Frame
In the week between 14 and 21 days post-treatment
Title
CR against Ascaris lumbricoides
Description
CR will be calculated as the percentage of Ascaris lumbricoides egg-positive participants at baseline who become egg-negative after treatment.
Time Frame
In the week between 14 and 21 days post-treatment
Title
ERR against Ascaris lumbricoides
Description
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).
Time Frame
In the week between 14 and 21 days post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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
Facility Information:
Facility Name
Public Health Laboratory - Ivo de Carneri
City
Chake Chake
ZIP/Postal Code
122
Country
Tanzania

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm

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