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

University of Oxford

Status and phase

Enrolling

Phase 2

Conditions

Scabies

Treatments

Drug: CHILD-IVITAB

Study type

Interventional

Funder types

Other

Identifiers

NCT06404333

PAR22001

Details and patient eligibility

About

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

Enrollment

66 estimated patients

Sex

All

Ages

3 months to 5 years old

Volunteers

No Healthy Volunteers

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