Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-11-10
Brief Title:
Evaluating Pediatric Ivermectin in Children Under 15 kg EPIC-15
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIC-15
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None