NCT06414694

Brief Summary

This study seeks to enroll patients admitted to a children's 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 patient's with drug allergies.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

1.8 years

First QC Date

April 25, 2024

Last Update Submit

May 9, 2024

Conditions

PenicillinDrug Allergy

Outcome Measures

Primary Outcomes (1)

  • Direct Oral Challenge

    Pass or Failure of direct oral challenge

    2 hours

Secondary Outcomes (2)

  • Follow-up at 48

    48 hours

  • Follow-up at 6 months

    6 months

Study Arms (1)

Direct Challenge

EXPERIMENTAL

Patients who met enrollment criteria proceed to direct oral challenge with penicillin with one hour observation, 48 hour phone call, six month follow-up.

Procedure: Direct Oral Challenge

Interventions

Direct Oral ChallengePROCEDURE

Direct oral challenge to penicillin at a goal dose of 45 mg/kg given in a 10%/90% dose

Direct Challenge

Eligibility Criteria

Age2 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients \>2 years
  • Patients identified via EMR as having a penicillin, amoxicillin, amoxicillin/clavulanic acid allergy

You may not qualify if:

  • Female patients aged \>8 years of age
  • Patients with hemodynamic instability
  • Patients identified with moderate or high risk histories per protocol
  • Patients currently taking oral antihistamines in 48 hours prior to direct challenge
  • Patients currently taking oral steroids in 48 hours prior to direct challenge
  • Patients currently receiving medications for nausea, shortness of breath,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2024

First Posted

May 16, 2024

Study Start

September 1, 2023

Primary Completion

June 30, 2025

Study Completion

September 30, 2025

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)