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

Hookworm Infections Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05017194
• Other study ID #: EMODEP_PEMBA
• Status: Completed
• Phase: Phase 2
• Start date: August 2, 2021
• Est. completion date: December 10, 2021

Study information

• Verified date: May 2022
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: December 10, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hookworm Infections
• Infections
• Trichuriasis
• Trichuris Trichiura; Infection

Intervention

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

Locations

Country	Name	City	State
Tanzania	Public Health Laboratory - Ivo de Carneri	Chake Chake

Sponsors (2)

Lead Sponsor	Collaborator
Jennifer Keiser	Public Health Laboratory Ivo de Carneri

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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).	In the week between 14 and 21 days post-treatment
Secondary	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.	In the week between 14 and 21 days post-treatment
Secondary	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).	In the week between 14 and 21 days post-treatment