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

Jennifer Keiser320 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

320

Conditions

Hookworm Infections

Interventions

EmodepsideDRUG

Treatment with Emodepside 30 mg

Albendazole 400mgDRUG

Treatment with Albendazole 400 mg

Eligibility

Sex: ALLMin age: 12 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Public Health Laboratory Ivo de Carneri

Chake Chake, Pemba, Tanzania

Outcomes

Primary Outcomes

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.

Time frame: In the week between 14 and 21 days post-treatment

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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