Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm

Jennifer Keiser442 enrolled

Overview

The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

442

Conditions

Trichuris Trichiura; Infection Hookworm Infections

Interventions

EmodepsideDRUG

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Public Health Laboratory - Ivo de Carneri

Chake Chake, Tanzania

Outcomes

Primary Outcomes

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.

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

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 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).

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

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.

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

ERR against Ascaris lumbricoides

Data from ClinicalTrials.gov

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