Evaluating Pediatric Ivermectin in Children Under 15 kg (EPIC-15)

Launched by UNIVERSITY OF OXFORD · May 3, 2024

Keywords

ClinConnect Summary

The EPIC-15 trial is a research study looking at a medicine called ivermectin to treat scabies in young children who weigh between 5 and 15 kilograms (about 11 to 33 pounds). Scabies is a skin condition caused by tiny mites that can make the skin very itchy and uncomfortable. This study aims to find out if ivermectin is safe, how the body processes it, and how well it works for children under 15 kg. The findings could help provide effective treatment options for these young children, allowing them to benefit from ivermectin therapy.

To participate in this trial, children need to be at least 3 months old and have scabies. They must weigh between 5 and 15 kg and be able to attend all study visits with their parents or guardians, who will need to give written consent. However, some children may not be eligible if they have certain health issues, like kidney or liver problems, or if they've recently participated in another study. If your child qualifies, they will receive the study medication and be monitored closely by the research team throughout the trial. This is an important step in ensuring that young children can receive the best possible care for scabies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female child weighing 5 to \<15 kilograms
• • ≥3 months old
• • Scabies infestation
• • Available to attend all study visits
• • Parents/guardians/carers able to provide written informed consent
• Exclusion Criteria:
• The participant may not enter the trial if ANY of the following apply:
• • A history of renal or hepatic impairment.
• • Any other significant disease or disorder (e.g. moderate or severe malnutrition) which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• • Participants who are participating or have participated in another research trial involving an investigational product in the past 12 weeks.
• • Children with Crusted/Norwegian scabies or severe secondary bacterial infections (e.g. sepsis)
• • Children who have taken ivermectin within the last month
• • Children with known allergies to ivermectin or excipients
• • Loa loa infection risk, assessed based on travel history to endemic areas
• • Use of prescription (especially CYP3A4 inhibitors or inducers) or non-prescription drugs (except paracetamol at doses of up to 90 milligrams/kg/day), including vitamins (especially vitamin C), herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 times the drug half-life (whichever is longer) prior to the first dose of study medication until the completion of the follow-up procedure, unless in the opinion of investigator, the medication will not interfere with the study procedures or compromise participants safety; the investigator will take advice from the manufacturer representative as necessary.
• • The investigator, health care provider or study staff feel that the participant is not suitable for study participation due to chronic illness, suspected underlying illness, or concerns that the participant will not adhere to follow-up schedule.
• • Being born prematurely.
• • Previously enrolled into this study