Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections

Launched by SWISS TROPICAL & PUBLIC HEALTH INSTITUTE · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called emodepside for adults and adolescents who have infections caused by certain worms, specifically *Trichuris trichiura*, *Ascaris lumbricoides*, and hookworms. The goal is to see how well emodepside works compared to a standard treatment known as mebendazole. The trial will include individuals who are at least 12 years old and have a confirmed worm infection, either alone or in combination with other worms.

To participate, individuals must be non-pregnant and not breastfeeding, and they need to have a certain level of worm eggs in their stool to qualify. Participants will provide written consent, and for younger individuals, parental consent may also be needed. Throughout the study, participants can expect regular check-ups to monitor their health and the effectiveness of the treatment. It's important to note that those with certain health conditions or who have recently taken specific medications may not be eligible for this trial. Overall, this study aims to help find better treatments for these common infections.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or non-pregnant (confirmed by a negative serum pregnancy test) and non-breastfeeding female participants aged 12 years and older.
• • 2. T. trichiura as a single infection or co-infection with hookworm and/or A. lumbricoides, confirmed by presence of T. trichiura eggs assessed by Kato-Katz thick smears from two stool samples (infection intensity defined as number of eggs per gram of stool (EPG): (1) light (1-999 EPG), (2) moderate to heavy (≥1000 EPG).
• • 3. A minimum infection intensity of 24 eggs per gram of stool at baseline and at least two positive slides out of the four slides assessed at baseline.
• • 4. Written informed consent signed by the participant and/or legally authorized representative(s) according to the participant's age as established per local regulations. In addition, participant's assent is required as applicable by local laws and regulations for adolescents of 12-17 years of age.
• • 5. Women of childbearing potential must agree to use an effective, culturally appropriate contraceptive measure from at least 28 days prior to first dosage for hormonal contraceptives only and for non-hormonal contraceptive measures from screening Visit 2 until End of Study Visit.
• Exclusion Criteria:
• • 1. Presence of any systemic illnesses, renal and/or hepatic impairment, any other acute or chronic health conditions or congenital disorders which, in the opinion of the Investigator, would make the participant unsuitable for participation in a clinical study or may interfere with the efficacy, safety, and/or pharmacokinetic (PK) evaluation of the study drug.
• 2. Any of the following:
• • 1. Platelet \<50,000/mm3
• • 2. Alanine Aminotransferase (ALT) or Serum Glutamic Pyruvic Transaminase (SGPT) \>3x upper limit of normal (ULN)
• • 3. Total bilirubin \>2xULN
• • 4. Estimated Glomerular Filtration Rate (eGFR) \<90 ml/min/1.73 m2 (adolescents) or estimated creatinine clearance (CrCl) \<90 ml/ min (adults)
• • 3. Treatment with the following anthelminthic drugs: albendazole, mebendazole, ivermectin, within 28 days before the first dose of study intervention or planned before End of Study Visit.
• • 4. Concomitant use as well as use within 14 days before the start of the first study intervention of strong CYP3A4 inhibitors or inducers, strong Pgp inducers and sensitive CYP3A4 substrates.
• • 5. Concomitant use of metronidazole from 2 days before the start of the first study intervention until 24 hours after last administration of study intervention.
• • 6. Previous assignment to a study intervention for another study planned to be administered during the period the participant is enrolled in this study (from date of informed consent to last follow-up).
• • 7. Known allergy/hypersensitivity to mebendazole and/or emodepside