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

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

Official Title
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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

Conditions
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Hookworm Infections

Intervention / Treatment
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* Drug: Emodepside
* Drug: Albendazole 400mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emodepside 30 mg<br> | Drug: Emodepside<br>* Treatment with Emodepside 30 mg<br>|
| Active Comparator: Albendazole 400 mg<br> | Drug: Albendazole 400mg<br>* Treatment with Albendazole 400 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hookworm, Emodepside, Efficacy, Safety, Confirmatory Stage, Soil Transmitted Helminth