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Allergy Testing of Patients Labeled as Penicillin Allergic

Allergy Testing of Primary Care Patients Labeled as Penicillin Allergic

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02983630
Enrollment
37
Registered
2016-12-06
Start date
2016-07-31
Completion date
2017-07-01
Last updated
2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Hypersensitivity

Brief summary

Patients labeled as penicillin allergic, rarely have this confirmed and being labeled as penicillin allergic is associated with increased health care costs, adverse effects and antibiotic resistance. The investigators will recruit participants from primary care practices labeled as penicillin allergic and offer allergy testing. The aim of this study is to develop a community, outpatient program for evaluation of penicillin allergy.

Interventions

OTHERPenicillin allergy testing

The standard protocol for testing for penicillin hypersensitivity, including initial skin testing with prick and intradermal evaluation followed by oral challenge if skin testing is negative.

Sponsors

Albany Medical College
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Labeled as having penicillin or amoxicillin allergy 2. Family history of penicillin allergy

Exclusion criteria

1. History of beta-lactam associated toxic epidermal necrolysis/Stevens Johnson syndrome to penicillin or amoxicillin 2. History of Drug induced Eosinophilia with Systemic Symptoms (DRESS) 3. History of drug induced: autoimmune hepatitis/interstitial nephritis, or hemolytic anemia 4. Poorly controlled asthma or heart disease 5. Currently pregnant 6. Unable to discontinue certain medications that may interfere with testing including (antihistamines, steroids, beta-blockers, tricyclic antidepressants, omalizumab)

Design outcomes

Primary

MeasureTime frame
Allergy testing for penicillin allergy results6 months

Secondary

MeasureTime frameDescription
Participant satisfaction after allergy testing with follow-up questionnaireWithin 6 months following testingA questionnaire will be provided to participants to review their experience with penicillin allergy testing, whether they will take penicillin in the future and if it is valuable information to be tested. Answers will be yes and no. This information will tell us
Development of new drug allergies following negative testing questionnaire6 months-2 yearsFollow-up questionnaire will be sent to participants to evaluate whether they have needed any antibiotics and if so, whether they've had any reactions. This will be two yes/no questions to assess the incidence of development of new allergic reaction following negative testing.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026