Allergy Testing of Patients Labeled as Penicillin Allergic

Allergy Testing of Primary Care Patients Labeled as Penicillin Allergic

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.

Study Overview

• Status: Completed
• Conditions: Drug Hypersensitivity
• Intervention / Treatment: Other: Penicillin allergy testing

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12203
      • Albany Medical College Allergy, Asthma and Immunology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults ages 18 and older from the general population.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Allergy testing for penicillin allergy results	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction after allergy testing with follow-up questionnaire	A 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	Within 6 months following testing
Development of new drug allergies following negative testing questionnaire	Follow-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.	6 months-2 years

Collaborators and Investigators

• Sponsor: Albany Medical College

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): June 30, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: September 22, 2016
• First Submitted That Met QC Criteria: December 5, 2016
• First Posted (ESTIMATE): December 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Drug-Related Side Effects and Adverse Reactions; Hypersensitivity; Drug Hypersensitivity; Anti-Infective Agents; Anti-Bacterial Agents; Penicillins
• Other Study ID Numbers: 4479