TTUHSC
Penicillin Delabeling
Research Study
Penicillin Allergy? Ditch the Label
ABOUT
Why Penicillin Allergies?
-
Penicillin allergies are very common (around 10% of the population), but many of these allergies are considered low-risk and can be removed after confirmatory testing.
-
Unnecessary penicillin allergy labels can be harmful. When unable to treat with penicillin products, doctors have to use medications that often have more side effects, are less effective at treating infections, or are more expensive.
-
Direct oral challenges (DOC) can be used to test if patients are still allergic to a medication. A small dose of medication is taken in a supervised medical setting and then the patient is watched for a short time for any reactions. Medications are on hand to quickly treat any reaction that happens because of the medication.
-
If no reaction happens after a receiving the medication the patient is allergic to, they have shown that they no longer develop an immediate allergic reaction to the medication in question. It is likely safe to remove this medication from the patient's allergy list after passing a DOC.
-
Using DOCs to remove penicillin allergies from a patient’s allergy list is a common practice. Traditionally, a patient participating in a DOC receives a low dose of amoxicillin (a common oral form of penicillin), waits for a period, and then takes a higher dose of amoxicillin (a two-step process). Recently, a one-step process, where patients take only the higher dose of amoxicillin, has been shown to be safe. The one-step and two-step processes have not yet been directly compared to each other in a research study. This study aims to compare the one-step and two-step DOCs for penicillin allergy.
Study Design
Recruitment
Participants will be recruited from the Texas Tech Physicians Internal Medicine and Family Medicine Clinics and from the Texas Tech University Health Sciences Center campus. Fliers with contact information will be posted to recruit patients. After submitting their contact information, potential participants will be contacted by the research team for additional screening and to set a clinic appointment for the study.
Criteria
Patients between the ages of 18-89 that meet the following eligibility criteria:
-
Have an allergy to penicillin or a penicillin-based antibiotic
-
Have a "low-risk" penicillin allergy as determined by the PEN-FAST scoring system
-
Are not currently pregnant (for female participants)
-
And other criteria that will be reviewed at the screening phone call
Challenge
-
Once participants have completed the screening phone call, they will be scheduled for a clinic appointment to complete the DOC. This appointment will last around 2 hours and will take place in the Texas Tech Physicians Internal Medicine Clinic.
-
They will be asked asked to take either a one-dose or two-dose (small, then large dose) treatment of amoxicillin (a common penicillin-based antibiotic). Placebo doses will be given so all participants will receive the same number of total doses. Participants will not know if they received the one- or two-dose amoxicillin treatment.
-
Participants will be monitored after they take the medication for any signs of allergic reaction and will be given treatment for allergic reaction if they do develop symptoms.
Risks and Benefits
Risks
-
Symptoms of an allergic reaction. This may include itchy skin rash, nausea, vomiting, diarrhea, abdominal discomfort, “stuffy”/ “runny” nose, sneezing, or wheezing.
-
A recent study similar to ours showed that in patients with a "low-risk" penicillin allergy, around 95% of patients no reaction at all. Among those that reacted (around 5%), there were no serious reactions.
-
Serious (though rare) risks involve anaphylaxis, including symptoms such as severe difficulty breathing, throat swelling or a drop in blood pressure. While a severe outcome such as death is theoretically possible, it is very unlikely in an observed medical setting.
Benefits
-
Participants that "pass" the DOC without any reactions will be considered penicillin non-allergic, and the penicillin allergy label will be removed from their medical chart. This means that they can be prescribed penicillin antibiotics when needed in the future.
-
Volunteering as a participant in this study will help the medical field further show that one-step DOC with amoxicillin is safe in low-risk patients, making this penicillin allergy delabeling more accessible to more people.
Want to join our study?
Contact us via this form to hear from one of our research team members!
​
Expect a phone call from one of our team members soon.
Questions? Email us at penicillin.delabelingstudy@gmail.com