## Protocol Section
### Identification Module
**NCT ID:** NCT06414694

**Brief Title:** Inpatient Penicillin Delabeling for Low-Risk Patients

**Official Title:** Inpatient Penicillin Delabeling for Low-Risk Patients

#### Organization Study ID Info
**ID:** 23-09373-FB
#### Organization
**Class:** OTHER
**Full Name:** University of Tennessee
### Status Module
#### Completion Date
**Date:** 2025-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-25
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Tennessee

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** False

### 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.

### Conditions Module

**Conditions:**

- Penicillin

- Drug Allergy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 25

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: Direct Oral Challenge

**Label:** Direct Challenge

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Direct Challenge

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

**Name:** Direct Oral Challenge

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Pass or Failure of direct oral challenge

**Measure:** Direct Oral Challenge

**Time Frame:** 2 hours

#### Secondary Outcomes

**Description:** 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.

**Measure:** Follow-up at 48

**Time Frame:** 48 hours

**Description:** Follow-up phone call to assess subsequent tolerance or reaction of penicillin based antibiotic if prescribed in this time period. Data to be collected by screening questionnaire.

**Measure:** Follow-up at 6 months

**Time Frame:** 6 months

### 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,

**Maximum Age:** 30 Years

**Minimum Age:** 2 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Memphis

**Country:** United States

**Facility:** University of Tennessee Health Science Center

**State:** Tennessee

**Zip:** 38163

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000064420

- Term: Drug-Related Side Effects and Adverse Reactions

- ID: D000064419

- Term: Chemically-Induced Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC25

- Name: Substance Related Disorders

### Condition Browse Module - Browse Leaves

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M7517

- Name: Drug Hypersensitivity

- Relevance: HIGH

- As Found: Drug Allergy

- ID: M30303

- Name: Drug-Related Side Effects and Adverse Reactions

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004342

- Term: Drug Hypersensitivity

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M13317

- Name: Penicillins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
