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

Launched by SWISS TROPICAL & PUBLIC HEALTH INSTITUTE · Dec 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called emodepside to see how well it works and how safe it is for treating infections caused by certain worms, specifically Trichuris trichiura, hookworms, and Ascaris lumbricoides. The researchers will compare emodepside to a medication that is already available called mebendazole. The trial is open to adults and teenagers aged 12 and older who have been diagnosed with these infections. To participate, individuals must have a specific level of infection confirmed by stool tests and must not have serious health issues that could interfere with the study.

Participants in this trial can expect to receive either emodepside or mebendazole, and they will be closely monitored for any side effects or changes in their health. The study is still in the planning stage and has not started recruiting participants yet. Before joining, eligible participants must provide written consent, and if they are teenagers, they may also need to give their agreement. It's important for women who could become pregnant to use effective birth control during the study. Overall, this trial aims to find a new treatment option for common worm infections that affect many people around the world.

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 P-gp inducers and sensitive CYP3A4 substrates (detailed list of prohibited medication is provided in Section 6.5.1).
• • 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