Drug HypersensitivityNCT02983630
Allergy Testing of Patients Labeled as Penicillin Allergic
An observational study of Drug Hypersensitivity, run by Albany Medical College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Hypersensitivity
- What is being tested?
- Penicillin allergy testing
- Type of treatment
- Pill or oral medicine
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 1 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults ages 18 and older from the general population.
Who may be able to join
- Labeled as having penicillin or amoxicillin allergy
- Family history of penicillin allergy
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Albany Medical College Allergy, Asthma and Immunology Center
Albany, New York, 12203
About this study
Official title: Allergy Testing of Primary Care 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.
- Conditions
- Drug Hypersensitivity
- Being tested
- Penicillin allergy testing
- Medical subject headings
- Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergy testing for penicillin allergy results
Measured: 6 months
Secondary outcomes (2)
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
Measured: Within 6 months following testing
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.
Measured: 6 months-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startJul 2016
- Primary completion30 Jun 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Britta Sundquist, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983630
- Sponsor's protocol ID
- 4479
- Status last verified
- Jan 2018
- First submitted
- 22 Sep 2016
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allergy Testing of Primary Care Patients Labeled as Penicillin Allergic
- ClinicalTrials.gov ID
- NCT02983630
- Acronym / sponsor ID
- 4479
- Conditions
- Drug Hypersensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults ages 18 and older from the general population.
Key inclusion criteria (2 listed)
- Labeled as having penicillin or amoxicillin allergy
- Family history of penicillin allergy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penicillin allergy testingThe 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. | Other | – |
Primary outcome
Allergy testing for penicillin allergy results
Time frame: 6 months
2 secondary outcomes
Participant satisfaction after allergy testing with follow-up questionnaire
Time frame: Within 6 months following testing
Development of new drug allergies following negative testing questionnaire
Time frame: 6 months-2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Hypersensitivity, run by Albany Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allergy testing for penicillin allergy results (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.