Allergy Testing of Patients Labeled as Penicillin Allergic

Drug Hypersensitivity Clinical Trial

Official title:

Allergy Testing of Primary Care Patients Labeled as Penicillin Allergic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983630
• Other study ID #: 4479
• Status: Completed
• Phase: N/A
• First received: September 22, 2016
• Last updated: January 8, 2018
• Start date: July 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: January 2018
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 1, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Drug Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Penicillin 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.

Locations

Country	Name	City	State
United States	Albany Medical College Allergy, Asthma and Immunology Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allergy testing for penicillin allergy results		6 months
Secondary	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
Secondary	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