Clinical trial NCT06404333: Evaluating Pediatric Ivermectin in Children Under 15 kg (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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Scabies
Keywords: ivermectin
pediatric
CHILD-IVITAB
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
name: Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta (FUAM)
name: University of Basel
name: ClinSearch
First posted: 2024-05-08
Enrollment: 66
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Population pharmacokinetic properties of ivermectin concentrations at escalating doses in children <15 kg
timeFrame: Days 0, 3, 7, 10, 14
Secondary outcomes:
measure: Safety of oral ivermectin measures by pruritus outcomes assessed by a composite score recorded on the diary cards.
timeFrame: Assessments will be performed at planned visits on days 0, 3, 7, 10, 14, and daily via diary cards.
measure: Safety of oral ivermectin measures by percentage of children with abnormal biochemistry laboratory value
timeFrame: Assessments will be performed at planned visits on days 0, 3, 7, 10, 14
measure: Safety of oral ivermectin measures by percentage of children with abnormal hematology laboratory value
timeFrame: Assessments will be performed at planned visits on days 0, 3, 7, 10, 14
measure: Safety of oral ivermectin as measured by percentage of children with abnormal neurological test result.
timeFrame: Assessments will be performed at planned visits on days 0, 3, 7, 10, 14.
measure: Acceptability of pediatric oral ivermectin assessed by score of assessment tools called ClinSearch Acceptability Score Test (CAST)
timeFrame: Days 0, 7
measure: Efficacy of pediatric oral ivermectin to treat scabies in children <15 kg as measured by scabies lesion counts
timeFrame: Days 0, 7, 14
Other outcomes:
measure: Pharmacogenomics of ivermectin
timeFrame: Day 0
Locations:
city: Manaus
country: Brazil
facility: Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta (FUAM)
Study officials:
affiliation: Mahidol Oxford Tropical Medicine Research Unit
name: Lorenz von Seidlein, Dr
role: PRINCIPAL_INVESTIGATOR
References: