Drug Challenges Without Prior Skin Testing
Drug Challenges Without Prior Skin Testing
The investigators are conducting a prospective study to determine the safety and outcomes of
 placebo-controlled graded drug challenges without prior skin testing in patients with a
 low-risk history of antibiotic hypersensitivity reaction based on history alone. The
 investigators hypothesize that the rate of reaction to graded drug challenges without prior
 skin testing in patients with a low-risk history of drug hypersensitivity reaction based on
 history alone will not be meaningfully more than the rate of reaction to placebo. The
 investigators hypothesize that the rate of adverse reactions to drug challenges without prior
 skin testing will not be meaningfully more than the rate of adverse reactions with prior skin
 testing as was observed in the investigators' historical clinic cohort.
Graded drug challenges are the gold standard to exclude an immediate hypersensitivity
 reaction in patients with a low likelihood of drug allergy and are considered standard of
 care. Patients who tolerate a graded challenge are deemed to not be allergic to the drug and
 are not at increased risk for future reactions compared with the general population. Prior
 studies of graded challenges in appropriately selected patients have demonstrated low
 reaction rates with symptoms that were mainly mild and subjective in nature. The
 investigators are conducting a prospective study to determine the safety and outcomes of
 placebo-controlled graded drug challenges without prior skin testing in patients with a
 low-risk history of antibiotic hypersensitivity reaction based on history alone. Skin testing
 requires a separate visit and is, therefore, more time-consuming and costly than performing a
 graded challenge without skin testing. The investigators believe that they can determine if
 patients are at low-risk to react to an antibiotic based on a detailed history and,
 therefore, do not require skin testing prior to a challenge. Given the majority of symptoms
 to graded drug challenges reported in prior studies were mild and subjective, the
 investigators hypothesize that the rate of reaction to graded drug challenges without prior
 skin testing in patients with a low-risk history of drug hypersensitivity reaction based on
 history alone will not be meaningfully more than the rate of reaction to placebo. The
 investigators hypothesize that the rate of adverse reactions to drug challenges without prior
 skin testing will be not meaningfully more than the rate of adverse reactions with prior skin
 testing as was observed in the investigators' historical clinic cohort. All patients age 7
 years or older with a history of a non-life-threatening reaction to an antibiotic are
 eligible to participate in a placebo-controlled graded drug challenge. The challenge is
 comprised of placebo followed by 30 minutes of observation, 1/10th of the treatment dose of
 the antibiotic the patient reported a reaction followed by 30 minutes of observation, and the
 full dose of the antibiotic followed by 1 hour of observation. All patients will be contacted
 via telephone within one month of a negative challenge to determine whether they experienced
 a delayed reaction. All patients will also be contacted via telephone within one year of a
 negative challenge to determine if they have safely taken the challenge drug.
Inclusion Criteria:

 -  All patients seven years of age or older who have a low-risk, non-life-threatening
 history of adverse reaction to an antibiotic.

 Exclusion Criteria:

 -  Patients under the age of seven.

 -  Pregnant patients.

 -  Patients with a history of a drug reaction that is high-risk and life-threatening
 including life-threatening angioedema, bronchospasm, or anaphylactic shock or a
 history of severe non-IgE-mediated reactions including serum sickness, Stevens-Johnson
 syndrome, toxic epidermal necrolysis, interstitial nephritis, hepatitis, hemolytic
 anemia, DRESS, skin and/or oral blisters, hypersensitivity vasculitis, pneumonitis, or
 pulmonary fibrosis.

 -  Patients who have taken antihistamines within 3 days of the drug challenge.