Evaluating ivermectin for treating scabies in young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The EPIC-15 trial aims to assess the safety, pharmacokinetics, acceptability, and efficacy of pediatric ivermectin (CHILD-IVITAB) in children under 15 kg who are infected with scabies. This interventional study will involve children aged 3 months and older, focusing on those weighing between 5 to less than 15 kg. By evaluating this treatment, the trial seeks to support the expansion of ivermectin's use to a younger demographic, ensuring equitable access to effective therapy for neglected tropical diseases.

Why it matters

Who can join: the full rules

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

Where it's running

• Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta (FUAM)
  Manaus, Brazil Recruiting

Study contacts

• Principal investigator: Lorenz von Seidlein, Dr — Mahidol Oxford Tropical Medicine Research Unit
• Study coordinator: Kevin Kobylinski, Dr
• Email: kevin@tropmedres.ac
• Phone: +66-(0)92-729-8013

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.