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Allergy Testing of Patients Labeled as Penicillin Allergic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02983630
Recruitment Status : Completed
First Posted : December 6, 2016
Last Update Posted : January 9, 2018
Information provided by (Responsible Party):
Britta Sundquist, Albany Medical College

Tracking Information
First Submitted Date September 22, 2016
First Posted Date December 6, 2016
Last Update Posted Date January 9, 2018
Actual Study Start Date July 2016
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 5, 2016)
Allergy testing for penicillin allergy results [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02983630 on Archive Site
Current Secondary Outcome Measures
 (submitted: December 5, 2016)
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Allergy Testing of Patients Labeled as Penicillin Allergic
Official Title Allergy Testing of Primary Care Patients Labeled as Penicillin Allergic
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults ages 18 and older from the general population.
Condition Drug 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 8, 2018)
Original Estimated Enrollment
 (submitted: December 5, 2016)
Actual Study Completion Date July 1, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility 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)
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT02983630
Other Study ID Numbers 4479
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Britta Sundquist, Albany Medical College
Study Sponsor Albany Medical College
Collaborators Not Provided
Investigators Not Provided
PRS Account Albany Medical College
Verification Date January 2018