Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm (NCT05017194) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm
Tanzania442 participantsStarted 2021-08-02
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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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
What they're measuring
1
Cure rate (CR) of emodepside against Trichuris trichiura
Timeframe: In the week between 14 and 21 days post-treatment
2
Cure rate (CR) of emodepside against hookworm
Timeframe: In the week between 14 and 21 days post-treatment