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

Scabies Clinical Trial

— EPIC-15  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06404333
• Other study ID #: PAR22001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: University of Oxford
• Contact: Kevin Kobylinski, Dr
• Phone: +66-(0)92-729-8013
• Email: kevin[@]tropmedres.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 5 Years

Eligibility

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.

• Previously enrolled into this study

Related Conditions & MeSH terms

• Scabies

Intervention

Drug:
• CHILD-IVITAB
Ivermectin (200 µg/kg) oro-dispersible minitablets
• CHILD-IVITAB
Ivermectin (400 µg/kg) oro-dispersible minitablets

Locations

Country	Name	City	State
Brazil	Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta (FUAM)	Manaus

Sponsors (5)

Lead Sponsor	Collaborator
University of Oxford	ClinSearch, Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta (FUAM), Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, University of Basel

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacogenomics of ivermectin	Whole genome sequencing of study participants will be performed and related to safety, pharmacokinetics, and treatment efficacy outcomes.	Day 0
Primary	Population pharmacokinetic properties of ivermectin concentrations at escalating doses in children <15 kg		Days 0, 3, 7, 10, 14
Secondary	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.
Secondary	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
Secondary	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
Secondary	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, and additional assessment on day 30.
Secondary	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
Secondary	Efficacy of pediatric oral ivermectin to treat scabies in children <15 kg as measured by scabies lesion counts		Days 0, 7, 14, 30