Hookworm Infections Clinical Trial
— EMODEP_PEMBAOfficial 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
Verified date | May 2022 |
Source | Swiss Tropical & Public Health Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm.
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 |
Country | Name | City | State |
---|---|---|---|
Tanzania | Public Health Laboratory - Ivo de Carneri | Chake Chake |
Lead Sponsor | Collaborator |
---|---|
Jennifer Keiser | Public Health Laboratory Ivo de Carneri |
Tanzania,
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 |
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