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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help children diagnosed with a penicillin allergy. By administering a small dose of penicillin under careful observation through a method called Direct Oral Challenge, doctors seek to confirm if the allergy is genuine. The goal is to safely remove the penicillin allergy label from those who aren't truly allergic, ensuring they receive appropriate treatment when needed. Children diagnosed with a penicillin allergy in their medical records and who have a low-risk history might be suitable candidates for this trial. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how it can benefit more patients.

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 is the safety track record for the direct oral challenge treatment?

Research has shown that taking penicillin directly by mouth is safe for most people. In several studies, adverse reactions to this method were rare, indicating that most individuals do not experience negative effects. This process helps determine true penicillin allergies and often reveals that individuals are not allergic.

One study found that this method can safely remove the penicillin allergy label for those at low risk, suggesting that many who believed they were allergic might actually tolerate penicillin without issues. Another study demonstrated that this method is effective and does not cause more reactions than other tests.

Overall, taking penicillin directly by mouth is well-tolerated, with most people not experiencing serious side effects. This makes it a reliable way to assess true penicillin allergies. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores a direct oral challenge with penicillin to address antibiotic allergies. Unlike traditional methods, which often rely on skin testing or avoidance of the suspected allergen, this approach directly tests tolerance to penicillin through a monitored oral intake. The potential benefits include quickly and accurately identifying individuals who can safely use penicillin, reducing unnecessary avoidance of this important antibiotic, and minimizing the use of broader-spectrum antibiotics that can contribute to resistance. This method could streamline the process of delabeling penicillin allergies, which is significant given that many reported allergies are not true allergies.

What evidence suggests that the Direct Oral Challenge is effective for penicillin allergy delabeling?

Research has shown that taking penicillin directly by mouth is safe and effective for those unlikely to be truly allergic. In this trial, participants will undergo a direct oral challenge with penicillin, which involves taking the medicine to test for allergies. Studies have found that this approach helps correct false allergy labels, enabling more people to use penicillin safely. This method is as effective as other ways to confirm that patients can handle penicillin. Overall, evidence supports that direct oral challenges effectively and safely prove that low-risk patients are not allergic to penicillin. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2806976

Efficacy of a Clinical Decision Rule to Enable Direct Oral ... Direct oral penicillin challenge is a safe and effective procedure that may facilitate the removal of a larger number of penicillin allergy labels.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37459086/

Efficacy of a Clinical Decision Rule to Enable Direct Oral ... In patients with a low-risk history, direct oral penicillin challenge is a safe procedure to facilitate the removal of a penicillin allergy ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10352926/

Efficacy of a Clinical Decision Rule to Enable Direct Oral ... In this randomized clinical trial, direct oral penicillin challenge in patients with a low-risk penicillin allergy was noninferior compared with ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S221321982500635X

A Randomized Trial Comparing Direct Challenges to ... Direct challenges (DCs) are safe and effective in evaluating penicillin allergies in low-risk, nonpregnant patients. Penicillin allergy evaluation in pregnancy ...

5. annallergy.org annallergy.org/article/S1081-1206(23)00250-8/fulltext

Direct challenges are the gold standard for most antibiotic ... Direct challenges (DCs) are an effective tool to evaluate low-risk (Fig 1) or unclear reaction histories to antibiotics and offer advantages over skin testing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9364402/

Use of a penicillin allergy clinical decision rule to enable ... The study's primary objective is to evaluate the non-inferiority of using PEN-FAST score-guided management with direct oral challenge compared ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8210118/

Safety and efficacy of de-labelling penicillin allergy in ... Conclusions. Direct oral challenge is safe and effective for de-labelling patients assessed as low risk for true allergy. Non-specialist clinicians competent in ...

8. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2823686

Reaction Risk to Direct Penicillin Challenges: A Systematic ... This systematic review and meta-analysis found that reactions to direct penicillin challenges are infrequent, with rates comparable to indirect challenges ...