NCT02983630

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

12 months

First QC Date

September 22, 2016

Last Update Submit

January 8, 2018

Conditions

Drug Hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • Allergy testing for penicillin allergy results

    6 months

Secondary Outcomes (2)

  • Participant satisfaction after allergy testing with follow-up questionnaire

    Within 6 months following testing

  • Development of new drug allergies following negative testing questionnaire

    6 months-2 years

Interventions

Penicillin allergy testingOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults ages 18 and older from the general population.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albany Medical College Allergy, Asthma and Immunology Center

Albany, New York, 12203, United States

Location

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor of Medicine

Study Record Dates

First Submitted

September 22, 2016

First Posted

December 6, 2016

Study Start

July 1, 2016

Primary Completion

June 30, 2017

Study Completion

July 1, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

US(1)