search
Back to results

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

Primary Purpose

Hookworm Infections

Status
Completed
Phase
Phase 2
Locations
Tanzania
Study Type
Interventional
Intervention
Emodepside
Albendazole 400mg
Sponsored by
Jennifer Keiser
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hookworm Infections focused on measuring Hookworm, Emodepside, Efficacy, Safety, Confirmatory Stage, Soil Transmitted Helminth

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female adults aged between 18 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

Sites / Locations

  • Public Health Laboratory Ivo de Carneri

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Emodepside 30 mg

Albendazole 400 mg

Arm Description

Outcomes

Primary Outcome Measures

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 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 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.
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).
Infection status and intensity assessed for at baseline and 14-21 days post-treatment by FECPAK-G2.

Full Information

First Posted
September 9, 2022
Last Updated
June 13, 2023
Sponsor
Jennifer Keiser
Collaborators
Public Health Laboratory Ivo de Carneri
search

1. Study Identification

Unique Protocol Identification Number
NCT05538767
Brief Title
Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
April 11, 2023 (Actual)
Study Completion Date
April 11, 2023 (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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hookworm Infections
Keywords
Hookworm, Emodepside, Efficacy, Safety, Confirmatory Stage, Soil Transmitted Helminth

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emodepside 30 mg
Arm Type
Experimental
Arm Title
Albendazole 400 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Emodepside
Intervention Description
Treatment with Emodepside 30 mg
Intervention Type
Drug
Intervention Name(s)
Albendazole 400mg
Intervention Description
Treatment with Albendazole 400 mg
Primary Outcome Measure Information:
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 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 of emodepside against Trichuris trichiura and Ascaris lumbricoides
Description
CR will be calculated as the percentage of Trichuris trichiura and 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 of the emodepside against Trichuris trichiura and Ascaris lumbricoides.
Description
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).
Time Frame
In the week between 14 and 21 days post-treatment
Title
Infection status and intensity assessed for at baseline and 14-21 days post-treatment by FECPAK-G2.
Time Frame
At baseline and 14-21 days post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Public Health Laboratory Ivo de Carneri
City
Chake Chake
State/Province
Pemba
ZIP/Postal Code
122
Country
Tanzania

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs