Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm (NCT05538767) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm
Tanzania320 participantsStarted 2022-09-16
Plain-language summary
To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 12-60, inclusive, infected with hookworm.
Who can participate
Age range12 Years – 60 Years
SexALL
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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
What they're measuring
1
Cure rate (CR) of emodepside against hookworm
Timeframe: In the week between 14 and 21 days post-treatment