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

Hookworm Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05538767
• Other study ID #: EMODEPSIDE_PEMBA
• Status: Completed
• Phase: Phase 2
• Start date: September 16, 2022
• Est. completion date: April 11, 2023

Study information

• Verified date: June 2023
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: April 11, 2023
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hookworm Infections

Intervention

Drug:
• Emodepside
Treatment with Emodepside 30 mg
• Albendazole 400mg
Treatment with Albendazole 400 mg

Locations

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

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 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 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 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.	In the week between 14 and 21 days post-treatment
Secondary	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).	In the week between 14 and 21 days post-treatment
Secondary	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