Inpatient Penicillin Delabeling for Low-Risk Patients | NCT06414694

Studies
Inpatient Penicillin Delabeling for Low-Risk Patients

NCT06414694

Sponsor

University of Tennessee

Status

Unknown status

Last Update Posted

May 16, 2024Actual

Enrollment

25Estimated

Phase

Phase 4

Conditions

Penicillin
Drug Allergy

Interventions

Direct Oral Challenge

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Actual

Primary Completion Date

Jun 30, 2025Estimated

Completion Date

Sep 30, 2025Estimated

First Submitted Date

Apr 25, 2024

First Submission Date that Met QC Criteria

May 9, 2024

First Posted Date

May 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2024

Last Update Posted Date

May 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This is a pilot study looking to utilize a novel criterion to identify low risk penicillin allergies for patients admitted to a children's hospital to evaluate safety and efficacy of direct oral challenges to patients with very low or low risk histories as identified in novel criterion.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Direct Oral Challenge	Procedure	Direct oral challenge to penicillin at a goal dose of 45 mg/kg given in a 10%/90% dose	Direct Challenge

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Direct Oral Challenge	Pass or Failure of direct oral challenge	2 hours

Secondary Outcomes

Measure	Description	Time Frame
Follow-up at 48	Follow-up phone call to assess adverse reaction by 48 hours. Data to be collected by screening questionnaire to assess for reactions such as fever, rash, manufacturer labeled adverse side effects.	48 hours
Follow-up at 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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,

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Tennessee Health Science Center		Memphis	Tennessee	38163	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004342	Drug Hypersensitivity

Ancestor Terms

ID	Term
D064420	Drug-Related Side Effects and Adverse Reactions
D064419	Chemically-Induced Disorders

Browse Leaves

Not provided

Browse Branches

Not provided