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CompletedNCT02983630Updated Jan 9, 2018

Allergy Testing of Patients Labeled as Penicillin Allergic

An observational study in Drug Hypersensitivity, sponsored by Albany Medical College. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-09.

Sponsored by Albany Medical College · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
37
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Drug Hypersensitivity
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In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 37 is below the median of 115 across 479 observational studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Albany Medical College is the lead sponsor of 80 studies on the registry; 14 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults ages 18 and older from the general population.

Inclusion criteria

  1. Labeled as having penicillin or amoxicillin allergy
  2. Family history of penicillin allergy

Exclusion criteria

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
37 participants (actual)
Patient registry
No

Interventions

  • OtherPenicillin 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.

06

What researchers measure

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

    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

    Time frame: Within 6 months following testing

  2. 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.

    Time frame: 6 months-2 years

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Study locations

1 site
  • Albany Medical College Allergy, Asthma and Immunology Center
    Albany, New York 12203, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02983630
Lead sponsor
Albany Medical College
Responsible party
Britta Sundquist (Instructor of Medicine, Albany Medical College) — Principal investigator
First posted
Dec 6, 2016
Start date
Jul 2016
Primary completion
Jun 30, 2017
Completion
Jul 1, 2017
Last update
Jan 9, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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