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

A Randomized Trial to Assess the Safety, Pharmacokinetics, Acceptability, and Efficacy of Pediatric Oral Ivermectin in Scabies Infected Children Weighing 5 to Less Than 15 Kilograms

The EPIC-15 trial will evaluate the safety, pharmacokinetics, acceptability, and efficacy of pediatric ivermectin (CHILD-IVITAB) in scabies infected children weighing 5 to less than 15 kg. This trial will support future efforts to expand the indication of ivermectin treatment to infants weighing 5 to less than 15 kg to treat numerous NTDs, allowing this young age group equitable access to the numerous benefits of pediatric ivermectin therapy

Study Overview

• Status: Completed
• Conditions: Scabies
• Intervention / Treatment: Drug: CHILD-IVITAB; Drug: CHILD-IVITAB

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Manaus, Brazil, 69065-130
    • Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta (FUAM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ivermectin (200 µg/kg)	Drug: CHILD-IVITAB; Ivermectin (200 µg/kg) oro-dispersible minitablets; Drug: CHILD-IVITAB; Ivermectin (400 µg/kg) oro-dispersible minitablets
Experimental: Ivermectin (400 µg/kg)	Drug: CHILD-IVITAB; Ivermectin (200 µg/kg) oro-dispersible minitablets; Drug: CHILD-IVITAB; Ivermectin (400 µg/kg) oro-dispersible minitablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Population pharmacokinetic properties of ivermectin concentrations at escalating doses in children <15 kg	Days 0, 3, 7, 10, 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of oral ivermectin measures by pruritus outcomes assessed by a composite score recorded on the diary cards.	Pruritus outcomes assessed by a composite score based on the behaviors displayed by the children as recorded on the diary cards.	Assessments will be performed at planned visits on days 0, 3, 7, 10, 14, and daily via diary cards.
Safety of oral ivermectin measures by percentage of children with abnormal biochemistry laboratory value	Biochemistry laboratory value, including Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT), creatinine, and total bilirubin.	Assessments will be performed at planned visits on days 0, 3, 7, 10, 14
Safety of oral ivermectin measures by percentage of children with abnormal hematology laboratory value	Hematology laboratory value including white blood cells, platelets, neutrophils, lymphocytes reported, hemoglobin, and hematocrit	Assessments will be performed at planned visits on days 0, 3, 7, 10, 14
Acceptability of pediatric oral ivermectin assessed by score of assessment tools called ClinSearch Acceptability Score Test (CAST)	ClinSearch Acceptability Score Test (CAST) reports a barycenter and its 90% confidence ellipses on a 3D-map to assess positive	Days 0, 7
Safety of oral ivermectin as measured by percentage of children with abnormal neurological test result.	Neurological test assesses by responses to a battery of stimuli with responses recorded as normal or abnormal.	Assessments will be performed at planned visits on days 0, 3, 7, 10, 14.
Efficacy of pediatric oral ivermectin to treat scabies in children <15 kg as measured by scabies lesion counts		Days 0, 7, 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacogenomics of ivermectin	Whole genome sequencing of study participants will be performed and related to safety, pharmacokinetics, and treatment efficacy outcomes.	Day 0

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: University of Basel; ClinSearch; Fundação de Medicina Tropical Dr. Heitor Vieira Dourado; Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta (FUAM)
• Investigators: Principal Investigator: Lorenz von Seidlein, Dr, Mahidol Oxford Tropical Medicine Research Unit

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: pediatric; ivermectin; CHILD-IVITAB
• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Skin Diseases; Skin Diseases, Infectious; Skin Diseases, Parasitic; Mite Infestations; Ectoparasitic Infestations; Skin and Connective Tissue Diseases; Scabies
• Other Study ID Numbers: PAR22001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: After publication
• IPD Sharing Access Criteria: Study data can be requested from the MORU Data Access Committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No