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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05017194
Other study ID # EMODEP_PEMBA
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
See also
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