Last updated 7 months ago
Evaluating Pediatric Ivermectin in Children Under 15 kg (EPIC-15)
66 patients around the world
Available in Brazil
University of Oxford
1Research sites
66Patients around the world
This study is for people with
Scabies
Requirements for the patient
To 5 Years
All Gender
Medical requirements
- 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.
- 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.Previously enrolled into this study.
Sites
Fundação Hospitalar de Dermatologia Tropical e Venereologia "Alfredo da Matta"
StudyEPIC-15
SponsorUniversity of Oxford
Conditions
Requirements
To 5 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06404333
