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Completed

NCT Number: NCT02983630

Allergy Testing of 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.

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Key information

Conditions

Drug Hypersensitivity Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Albany Medical College Allergy, Asthma and Immunology Center

Albany, New York, 12203, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Labeled as having penicillin or amoxicillin allergy
  • Family history of penicillin allergy

Exclusion criteria

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

Treatment and study plan

Penicillin allergy testing

Other

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.

Primary outcomes

  1. Allergy testing for penicillin allergy results

    Time frame: 6 months

Secondary outcomes

  1. Participant satisfaction after allergy testing with follow-up questionnaire

    Time frame: Within 6 months following testing

    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

  2. Development of new drug allergies following negative testing questionnaire

    Time frame: 6 months-2 years

    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.

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Official study title

Allergy Testing of Primary Care Patients Labeled as Penicillin Allergic

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2016
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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