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

NCT06404333 | Completed Phase 2 DMC

• 1 other identifier: PAR22001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Scabies

Keywords

ivermectin; pediatric; CHILD-IVITAB

Outcome Measures

Primary Outcomes (1)

• Population pharmacokinetic properties of ivermectin concentrations at escalating doses in children <15 kg

  Days 0, 3, 7, 10, 14

Secondary Outcomes (6)

• Safety of oral ivermectin measures by pruritus outcomes assessed by a composite score 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

  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

  Assessments will be performed at planned visits on days 0, 3, 7, 10, 14

• Safety of oral ivermectin as measured by percentage of children with abnormal neurological test result.

  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)

  Days 0, 7

Other Outcomes (1)

• Pharmacogenomics of ivermectin

  Day 0

Study Arms (2)

Ivermectin (200 µg/kg)

EXPERIMENTAL

Drug: CHILD-IVITAB

Ivermectin (400 µg/kg)

EXPERIMENTAL

Drug: CHILD-IVITAB

Interventions

CHILD-IVITAB DRUG

Ivermectin (200 µg/kg) oro-dispersible minitablets

Ivermectin (200 µg/kg)

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ClinSearch: collaborator
• University of Oxford: lead
• Fundação de Medicina Tropical Dr. Heitor Vieira Dourado: collaborator
• Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta (FUAM): collaborator
• University of Basel: collaborator

Study Sites (1)

Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta (FUAM)

Manaus, 69065-130, Brazil

Location

MeSH Terms

Conditions

Scabies

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lorenz von Seidlein, Dr

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: May 8, 2024
• Study Start: February 25, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication
• Access Criteria: Study data can be requested from the MORU Data Access Committee.

Locations

BR (1)