Ivermectin Safety in Small Children

Launched by UNIVERSITY OF OXFORD · Apr 1, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a medication called ivermectin for treating scabies in young children who weigh between 5 and 15 kilograms. Scabies is a skin condition caused by tiny mites that can lead to itching and discomfort. The goal of this study is to understand how safe ivermectin is for this age group, which will help ensure that even the youngest children can benefit from its use in treating various diseases.

To participate in this trial, children must be at least 2 months old, have a confirmed case of scabies, and weigh between 5 and 15 kilograms. Parents or guardians will need to provide consent for their child's participation. Throughout the study, participants will attend several visits where their health will be monitored. It's important to note that children with certain health issues or those who have recently received other treatments may not be eligible. This trial aims to give families more options for treating scabies safely and effectively in young children.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female child weighing 5 to \<15 kilograms
• • ≥2 months old
• • Scabies infestation
• • Available to attend all study visits
• • Parents/guardians/carers able to provide 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 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 or topical permethrin cream within the last two weeks
• • Children with known allergies to ivermectin or topical permethrin cream 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 patient safety; the investigator will take advice from the manufacturer representative as necessary.
• • The investigator, health care provider or study staff feel that the patient is not suitable for study participation due to chronic illness, suspected underlying illness, or concerns that the patient will adhere to follow-up schedule.
• • Previously treated in the ISSC study