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Allergy Testing of Patients Labeled as Penicillin Allergic

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ClinicalTrials.gov Identifier: NCT02983630
Recruitment Status : Completed
First Posted : December 6, 2016
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Britta Sundquist, Albany Medical College

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.

Condition or disease Intervention/treatment
Drug Hypersensitivity Other: Penicillin allergy testing

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Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Allergy Testing of Primary Care Patients Labeled as Penicillin Allergic
Actual Study Start Date : July 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Penicillins


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Allergy testing for penicillin allergy results [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults ages 18 and older from the general population.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983630


Locations
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United States, New York
Albany Medical College Allergy, Asthma and Immunology Center
Albany, New York, United States, 12203
Sponsors and Collaborators
Albany Medical College

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Responsible Party: Britta Sundquist, Instructor of Medicine, Albany Medical College
ClinicalTrials.gov Identifier: NCT02983630     History of Changes
Other Study ID Numbers: 4479
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
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Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Penicillins
Anti-Bacterial Agents
Anti-Infective Agents