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

NCT ID: NCT06404333

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2025-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ivermectin (200 µg/kg)

Group Type: EXPERIMENTAL

CHILD-IVITAB

Intervention Type: DRUG

Ivermectin (200 µg/kg) oro-dispersible minitablets

Ivermectin (400 µg/kg)

Group Type: EXPERIMENTAL

CHILD-IVITAB

Intervention Type: DRUG

Ivermectin (400 µg/kg) oro-dispersible minitablets

Interventions

CHILD-IVITAB

Ivermectin (200 µg/kg) oro-dispersible minitablets

Intervention Type: DRUG

CHILD-IVITAB

Ivermectin (400 µg/kg) oro-dispersible minitablets

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

OTHER

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

University of Basel

OTHER

Sponsor Role: collaborator

ClinSearch

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenz von Seidlein, Dr

Role: PRINCIPAL_INVESTIGATOR

Mahidol Oxford Tropical Medicine Research Unit

Locations

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

Manaus, , Brazil

Countries

Brazil

Other Identifiers

PAR22001

Identifier Type: -

Identifier Source: org_study_id