Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414694
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-16
First Post:
2024-04-25
Brief Title:
Inpatient Penicillin Delabeling for Low-Risk Patients
Sponsor:
University of Tennessee
Organization:
University of Tennessee
Study Overview
Official Title:
Inpatient Penicillin Delabeling for Low-Risk Patients
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
None
Brief Summary:
This study seeks to enroll patients admitted to a childrens hospital with identified penicillin allergy A screening checklist is performed to identify patients with very low or low risk histories of penicillin allergy to offer direct oral challenges to the antibiotic class to de-label patients with drug allergies
Detailed Description:
This is a pilot study looking to utilize a novel criterion to identify low risk penicillin allergies for patients admitted to a childrens hospital to evaluate safety and efficacy of direct oral challenges to patients with very low or low risk histories as identified in novel criterion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None