Penicillin Delabeling for Antibiotic Allergy

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Tennessee

Must not be taking: Antihistamines, Steroids, Nausea meds

Disqualifiers: Female >8 years, Hemodynamic instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications before participating in the trial. Specifically, you should not take oral antihistamines or oral steroids within 48 hours before the direct challenge. If you are taking medications for nausea or shortness of breath, you may also need to stop those.

What data supports the effectiveness of the treatment Direct Oral Challenge for Penicillin Delabeling?

Research shows that direct oral challenge is a quick and cost-effective way to remove incorrect penicillin allergy labels, improving health outcomes. It is as effective as traditional skin testing followed by oral challenge for people with low-risk penicillin allergies. ^{1 2 3 4 5}

Is penicillin delabeling through direct oral challenge safe for humans?

Research shows that direct oral challenges to remove incorrect penicillin allergy labels are generally safe, with most patients successfully delabeled without adverse effects. However, more safety data is needed to ensure these programs can be widely implemented. ^{1 2 4 6 7}

How is the direct oral challenge treatment for penicillin allergy unique?

The direct oral challenge treatment is unique because it offers a rapid and cost-effective way to remove inaccurate penicillin allergy labels by directly administering the drug to patients, unlike traditional methods that require both skin and challenge tests, which are more expensive and time-consuming. ^{2 3 4 5 8}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for patients admitted to a children's hospital who have been labeled with a penicillin allergy. It specifically seeks those considered at very low or low risk of having an actual allergy, based on a screening checklist.

Inclusion Criteria

I am older than 2 years.

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

Exclusion Criteria

I am a female older than 8 years.

Patients with hemodynamic instability

Patients identified with moderate or high risk histories per protocol

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Not specified

Direct Oral Challenge

Participants undergo a direct oral challenge with penicillin followed by one hour of observation

2 hours

1 visit (in-person)

Follow-up

Follow-up phone call to assess adverse reactions by 48 hours

48 hours

Extended Follow-up

Follow-up phone call to assess subsequent tolerance or reaction of penicillin-based antibiotic if prescribed

6 months

Treatment Details

Interventions

• Direct Oral Challenge

Trial Overview The study involves giving these low-risk patients a direct oral challenge with penicillin-based antibiotics to see if they can safely remove the 'allergic' label from their medical records.

Participant Groups

Group I: Direct Challenge Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Tennessee

Lead Sponsor

Trials

202

Recruited

146,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

The Penicillin Allergy Delabeling Program: A Multicenter Whole-of-Hospital Health Services Intervention and Comparative Effectiveness Study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Sustaining and spreading penicillin allergy delabelling: A narrative review of the challenges for service delivery and patient safety. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

In low-risk penicillin allergies, direct oral challenge was noninferior to skin testing followed by oral challenge. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The democratization of de-labeling: a review of direct oral challenge in adults with low-risk penicillin allergy. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Penicillin allergy de-labelling ahead of elective surgery: feasibility and barriers. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of direct two-step penicillin challenges with an inpatient pharmacist-driven allergy evaluation. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Direct challenges are the gold standard for most antibiotic allergy evaluations. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Improving antimicrobial stewardship with penicillin allergy testing: a review of current practices and unmet needs. [2022]